Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317408
Status:
UNKNOWN
Last Update Posted:
2015-09-25
First Post:
2006-04-19
Brief Title:
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma
Sponsor:
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patients or a donors stem cells helps stop both the growth of cancer cells and the patients immune system from rejecting the stem cells When the stem cells are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma
PURPOSE This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma
PURPOSE This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma ALCL andor relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation
Determine whether a conditioning regimen comprising carmustine etoposide phosphate cytarabine and melphalan BEAM without total body irradiation for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment
Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy
Secondary
Determine overall survival and treatment-related mortality in patients treated with these regimens
Determine acute and long-term toxicity in patients treated with these regimens
Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation
OUTLINE This is a multicenter prospective nonrandomized study Patients are stratified according to time from initial diagnosis to progressionrelapse immunophenotype of lymphoma cells CD3-positive vs CD3-negative stem cell donor availability matched sibling donor vs 910 or 1010 matched unrelated donor and vinblastine during frontline therapy yes vs no
Group 1 early progression Patients receive 1 course of ICM chemotherapy followed by 1 course of ICI chemotherapy
ICM chemotherapy Patients receive methotrexate cytarabine and prednisolone intrathecally IT on day 1 mitoxantrone hydrochloride IV over 5 hours on days 1 and 2 carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6
ICI chemotherapy Patients receive methotrexate cytarabine and prednisolone intrathecally on day 1 idarubicin IV over 4 hours on days 1 and 2 carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6
Patients then proceed to allogeneic stem cell transplantation
Group 2 relapsed disease and CD3-positive lymphoma cells Patients are stratified according to stem cell donor availability yes vs no
Available donor Patients receive 2 courses of CC chemotherapy and then proceed to allogeneic stem cell transplantation
Unavailable donor Patients receive 2 courses of CC chemotherapy comprising dexamethasone orally or IV on days 1-5 vindesine IV on day 1 cytarabine IV over 3 hours on days 1 and 2 etoposide phosphate IV over 2 hours on days 3-5 and methotrexate cytarabine and prednisolone IT on day 5 Patients then receive 1 course of CVA chemotherapy comprising oral lomustine on day 1 vinblastine IV on days 1 8 15 and 22 and cytarabine IV over 1 hour on days 1-5 Patients undergo leukapheresis for collection of autologous peripheral blood stem cells after the first andor second course of CC chemotherapy Patients then proceed to autologous stem cell transplantation
Group 3 relapsed disease CD3-negative immunophenotype and received vinblastine during frontline therapy Patients receive 2 courses of CC chemotherapy and 1 course of CVA chemotherapy as described above Patients undergo leukapheresis for collection of autologous peripheral blood stem cells PBSC after the first andor second course of CC chemotherapy Patients then proceed to autologous stem cell transplantation
Group 4 late relapse CD3-negative immunophenotype and did not receive vinblastine during frontline therapy Patients receive vinblastine IV once weekly for 24 months Patients with disease progression during or relapsed disease after vinblastine therapy undergo treatment as in group 3
Autologous stem cell transplantation SCT Patients receive a conditioning regimen comprising carmustine IV over 1 hour on day -7 etoposide phosphate IV over 1 hour and cytarabine IV over 30 minutes on days -6 to -3 and melphalan IV over 15 minutes on day -2 Patients undergo autologous SCT on day 0
Allogeneic SCT Beginning 4-6 weeks after the start of the last chemotherapy course patients receive 1 of the following conditioning regimens based on age
Patients 2 years of age undergo total body irradiation on days -7 to -5 and receive thiotepa IV over 1 hour on day -4 and etoposide IV over 4 hours on day -3 Patients undergo allogeneic SCT on day 0
Patients 2 years of age receive oral busulfan 4 times daily on days -8 to -5 thiotepa IV over 1 hour twice on day -4 and etoposide phosphate IV over 4 hours on day -3 Patients undergo allogeneic SCT on day 0
Patients undergoing SCT from an unrelated donor also receive antithymocyte globulin IV over 4 hours on days -3 to -1
All patients receive graft-versus-host GVHD prophylaxis as described below
GVHD prophylaxis GVHD prophylaxis is administered as per donor status
Matched sibling donor Patients receive cyclosporine IV over 2 hours or orally on day -1 to 60 followed by a taper
1010 or 910 matched unrelated donor Patients receive cyclosporine IV over 2 hours or orally on days -1 to 100 followed by a taper methotrexate IV on days 1 3 and 6 and leucovorin calcium IV on days 2 4 and 7
Mismatched donor Patients do not receive GVHD prophylaxis however CD3-positive lymphocytes are extracted from donor stem cells
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
Primary
Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma ALCL andor relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation
Determine whether a conditioning regimen comprising carmustine etoposide phosphate cytarabine and melphalan BEAM without total body irradiation for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment
Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy
Secondary
Determine overall survival and treatment-related mortality in patients treated with these regimens
Determine acute and long-term toxicity in patients treated with these regimens
Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation
OUTLINE This is a multicenter prospective nonrandomized study Patients are stratified according to time from initial diagnosis to progressionrelapse immunophenotype of lymphoma cells CD3-positive vs CD3-negative stem cell donor availability matched sibling donor vs 910 or 1010 matched unrelated donor and vinblastine during frontline therapy yes vs no
Group 1 early progression Patients receive 1 course of ICM chemotherapy followed by 1 course of ICI chemotherapy
ICM chemotherapy Patients receive methotrexate cytarabine and prednisolone intrathecally IT on day 1 mitoxantrone hydrochloride IV over 5 hours on days 1 and 2 carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6
ICI chemotherapy Patients receive methotrexate cytarabine and prednisolone intrathecally on day 1 idarubicin IV over 4 hours on days 1 and 2 carboplatin IV continuously on days 2-5 and ifosfamide IV continuously on days 2-6
Patients then proceed to allogeneic stem cell transplantation
Group 2 relapsed disease and CD3-positive lymphoma cells Patients are stratified according to stem cell donor availability yes vs no
Available donor Patients receive 2 courses of CC chemotherapy and then proceed to allogeneic stem cell transplantation
Unavailable donor Patients receive 2 courses of CC chemotherapy comprising dexamethasone orally or IV on days 1-5 vindesine IV on day 1 cytarabine IV over 3 hours on days 1 and 2 etoposide phosphate IV over 2 hours on days 3-5 and methotrexate cytarabine and prednisolone IT on day 5 Patients then receive 1 course of CVA chemotherapy comprising oral lomustine on day 1 vinblastine IV on days 1 8 15 and 22 and cytarabine IV over 1 hour on days 1-5 Patients undergo leukapheresis for collection of autologous peripheral blood stem cells after the first andor second course of CC chemotherapy Patients then proceed to autologous stem cell transplantation
Group 3 relapsed disease CD3-negative immunophenotype and received vinblastine during frontline therapy Patients receive 2 courses of CC chemotherapy and 1 course of CVA chemotherapy as described above Patients undergo leukapheresis for collection of autologous peripheral blood stem cells PBSC after the first andor second course of CC chemotherapy Patients then proceed to autologous stem cell transplantation
Group 4 late relapse CD3-negative immunophenotype and did not receive vinblastine during frontline therapy Patients receive vinblastine IV once weekly for 24 months Patients with disease progression during or relapsed disease after vinblastine therapy undergo treatment as in group 3
Autologous stem cell transplantation SCT Patients receive a conditioning regimen comprising carmustine IV over 1 hour on day -7 etoposide phosphate IV over 1 hour and cytarabine IV over 30 minutes on days -6 to -3 and melphalan IV over 15 minutes on day -2 Patients undergo autologous SCT on day 0
Allogeneic SCT Beginning 4-6 weeks after the start of the last chemotherapy course patients receive 1 of the following conditioning regimens based on age
Patients 2 years of age undergo total body irradiation on days -7 to -5 and receive thiotepa IV over 1 hour on day -4 and etoposide IV over 4 hours on day -3 Patients undergo allogeneic SCT on day 0
Patients 2 years of age receive oral busulfan 4 times daily on days -8 to -5 thiotepa IV over 1 hour twice on day -4 and etoposide phosphate IV over 4 hours on day -3 Patients undergo allogeneic SCT on day 0
Patients undergoing SCT from an unrelated donor also receive antithymocyte globulin IV over 4 hours on days -3 to -1
All patients receive graft-versus-host GVHD prophylaxis as described below
GVHD prophylaxis GVHD prophylaxis is administered as per donor status
Matched sibling donor Patients receive cyclosporine IV over 2 hours or orally on day -1 to 60 followed by a taper
1010 or 910 matched unrelated donor Patients receive cyclosporine IV over 2 hours or orally on days -1 to 100 followed by a taper methotrexate IV on days 1 3 and 6 and leucovorin calcium IV on days 2 4 and 7
Mismatched donor Patients do not receive GVHD prophylaxis however CD3-positive lymphocytes are extracted from donor stem cells
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2005-003321-57 | None | None | None |
| EICNHL-ALCL-RELAPSE | None | None | None |
| AIEOP-EICNHL-ALCL-RELAPSE | None | None | None |
| BFM-EICNHL-ALCL-RELAPSE | None | None | None |
| BSPHO-EICNHL-ALCL-RELAPSE | None | None | None |
| DCOG-EICNHL-ALCL-RELAPSE | None | None | None |
| NOPHO-EICNHL-ALCL-RELAPSE | None | None | None |
| PPLLSG-EICNHL-ALCL-RELAPSE | None | None | None |
| SFCE-EICNHL-ALCL-RELAPSE | None | None | None |
| SHOP-EICNHL-ALCL-RELAPSE | None | None | None |
| CCLG-NHL-2006-01 | None | None | None |
| EU-205118 | None | None | None |
| EU-20618 | None | None | None |