Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002565
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkins Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ATT VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
Status:
COMPLETED
Status Verified Date:
2018-11
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
I Compare in a randomized setting the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP cyclophosphamide doxorubicin vincristine prednisone versus the new alternating triple therapy ATT of IdSHAP idarubicin cisplatin cytarabine methylprednisolone BIdCOS idarubicin vincristine bleomycin cyclophosphamide methylprednisolone and MINE mesna ifosfamide mitoxantrone etoposide
II Compare the complete response rate achieved with ATT versus standard CHOP
III Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support
IV Compare the predictive capability of the MD Anderson Tumor Score System versus the International Index System
OUTLINE Randomized study The following acronyms are used ARA-C Cytarabine NSC-63878 BLEO Bleomycin NSC-125066 CDDP Cisplatin NSC-119875 CTX Cyclophosphamide NSC-26271 DHAD Mitoxantrone NSC-301739 DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor source unspecified IDA Idarubicin NSC-256439 IFF Ifosfamide NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate NSC-113891 PRED Prednisone NSC-10023 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540
Arm I Sequential 4- 5- and 3-Drug Combination Chemotherapy IdSHAP IDACDDPARA-CMePRDL followed by BIdCOS BLEOIDACTXVCRMePRDL followed by MINE MesnaIFFDHADVP-16
Arm II 4-Drug Combination Chemotherapy CHOP CTXDOXVCRPRED
PROJECTED ACCRUAL 218 evaluable patients will be accrued over approximately 31 months to this multicenter study If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures consideration will be given to early closure
I Compare in a randomized setting the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP cyclophosphamide doxorubicin vincristine prednisone versus the new alternating triple therapy ATT of IdSHAP idarubicin cisplatin cytarabine methylprednisolone BIdCOS idarubicin vincristine bleomycin cyclophosphamide methylprednisolone and MINE mesna ifosfamide mitoxantrone etoposide
II Compare the complete response rate achieved with ATT versus standard CHOP
III Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support
IV Compare the predictive capability of the MD Anderson Tumor Score System versus the International Index System
OUTLINE Randomized study The following acronyms are used ARA-C Cytarabine NSC-63878 BLEO Bleomycin NSC-125066 CDDP Cisplatin NSC-119875 CTX Cyclophosphamide NSC-26271 DHAD Mitoxantrone NSC-301739 DOX Doxorubicin NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor source unspecified IDA Idarubicin NSC-256439 IFF Ifosfamide NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate NSC-113891 PRED Prednisone NSC-10023 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540
Arm I Sequential 4- 5- and 3-Drug Combination Chemotherapy IdSHAP IDACDDPARA-CMePRDL followed by BIdCOS BLEOIDACTXVCRMePRDL followed by MINE MesnaIFFDHADVP-16
Arm II 4-Drug Combination Chemotherapy CHOP CTXDOXVCRPRED
PROJECTED ACCRUAL 218 evaluable patients will be accrued over approximately 31 months to this multicenter study If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures consideration will be given to early closure
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 |
|---|---|---|---|
| DM94-017 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-94017 | None | None | None |
| NCI-T94-0040D | None | None | None |