Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025038
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplant in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Window Evaluation of the Farnesyl Transferase Inhibitor R115777 Followed by 13-CIS Retinoic Acid Cytosine Arabinoside and Fludarabine Plus Hematopoietic Stem Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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:
Giving chemotherapy drugs such as R115777 isotretinoin cytarabine and fludarabine before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate of children with newly diagnosed juvenile myelomonocytic leukemia treated with R115777 isotretinoin cytarabine and fludarabine followed by allogeneic bone marrow or umbilical cord blood transplantation
II Determine the safety and toxicity of this regimen in these patients III Determine the tolerability of this regimen in these patients IV Determine the rate of 2-year event-free survival of patients treated with this regimen
V Determine whether prognostic subsets of these patients can be identified based on expression of clinical genetic NFI monosomy 7 RAS gene or hematopoietic characteristics
OUTLINE This is a multicenter study
Patients may choose to receive upfront window induction therapy with oral R115777 twice daily on days 1-21 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease or stable disease with unacceptable hematopoietic recovery after 1 course proceed to induction chemotherapy R11577 portion of the study closed to accrual as of 082005
All patients receive induction chemotherapy comprising oral isotretinoin once daily beginning on day 1 and fludarabine IV over 30 minutes and cytarabine IV over 4 hours on days 1-5 Treatment with fludarabine and cytarabine repeats every 28 days for 2 courses Treatment with isotretinoin continues until allogeneic bone marrow or umbilical cord blood transplantation Patients with progressive disease after 1 course proceed to transplantation
After completion of isotretinoin patients receive a preparative regimen comprising total body irradiation twice daily on days -7 to -4 cyclophosphamide IV over 2 hours on days -3 and -2 and anti-thymocyte globulin IV over 4-6 hours every 12 hours on days -3 to -1 Patients undergo allogeneic bone marrow or umbilical cord blood transplantation on day 0 Patients receive oral isotretinoin daily beginning on approximately day 60 and continuing for 1 year
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 100 patients 18-46 receiving R115777 with induction chemotherapy R11577 portion of the study closed to accrual as of 082005 and 27-54 receiving induction chemotherapy only will be accrued for this study within 32 years
I Determine the response rate of children with newly diagnosed juvenile myelomonocytic leukemia treated with R115777 isotretinoin cytarabine and fludarabine followed by allogeneic bone marrow or umbilical cord blood transplantation
II Determine the safety and toxicity of this regimen in these patients III Determine the tolerability of this regimen in these patients IV Determine the rate of 2-year event-free survival of patients treated with this regimen
V Determine whether prognostic subsets of these patients can be identified based on expression of clinical genetic NFI monosomy 7 RAS gene or hematopoietic characteristics
OUTLINE This is a multicenter study
Patients may choose to receive upfront window induction therapy with oral R115777 twice daily on days 1-21 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease or stable disease with unacceptable hematopoietic recovery after 1 course proceed to induction chemotherapy R11577 portion of the study closed to accrual as of 082005
All patients receive induction chemotherapy comprising oral isotretinoin once daily beginning on day 1 and fludarabine IV over 30 minutes and cytarabine IV over 4 hours on days 1-5 Treatment with fludarabine and cytarabine repeats every 28 days for 2 courses Treatment with isotretinoin continues until allogeneic bone marrow or umbilical cord blood transplantation Patients with progressive disease after 1 course proceed to transplantation
After completion of isotretinoin patients receive a preparative regimen comprising total body irradiation twice daily on days -7 to -4 cyclophosphamide IV over 2 hours on days -3 and -2 and anti-thymocyte globulin IV over 4-6 hours every 12 hours on days -3 to -1 Patients undergo allogeneic bone marrow or umbilical cord blood transplantation on day 0 Patients receive oral isotretinoin daily beginning on approximately day 60 and continuing for 1 year
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 100 patients 18-46 receiving R115777 with induction chemotherapy R11577 portion of the study closed to accrual as of 082005 and 27-54 receiving induction chemotherapy only will be accrued for this study within 32 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068788 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA098543 |
| AAML0122 | None | None | None |
| U10CA098543 | NIH | None | None |