Lymphoma Clinical Trial
Official title:
A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone ("ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells. It is
not yet known which regimen of combination chemotherapy is more effective for acute
lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and
comparing them to see how well they work in treating adults with acute lymphoblastic
leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.
OBJECTIVES:
- Compare the incidence of complete remission (CR) following induction with the ALL-2
regimen (cytarabine and high-dose mitoxantrone) vs the L-20 regimen (vincristine and
prednisone) in previously untreated adult patients with acute lymphoblastic leukemia
(ALL), lymphoblastic lymphoma, and lymphoid blast crisis chronic myelogenous leukemia.
- Compare the time to CR, length of hospital stay, efficacy of treatment in Philadelphia
chromosome-positive ALL, and the proportion of patients achieving durable (greater than
5 years) remission in each treatment regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating institution and antecedent lymphoid blast crisis of chronic myelogenous
leukemia (yes vs no). Patients are randomized to one of two treatment arms.
Arm I:
- Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5
with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4.
Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on
day 7 and continuing until blood counts recover.
- At 7-14 days following induction therapy, patients receive consolidation therapy
consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times
daily on days 1-30 and methotrexate intrathecally on days 8, 15, 22, and 29.
- At 2-3 weeks following the last dose of vincristine, patients receive an additional
course of consolidation therapy consisting of cyclophosphamide IV on day 1 and GM-CSF
subcutaneously beginning on day 3 and continuing until blood counts recover.
- At 3-4 weeks following the second consolidation course, patients receive a third course
of consolidation therapy consisting of cytarabine IV bolus on day 1 followed by
continuous infusion cytarabine on days 1-4 with etoposide IV over 1 hour on days 1-3
and methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously
beginning on day 6 and continuing until blood counts recover.
- Following recovery from the third consolidation course, patients receive a fourth
consolidation course consisting of pegaspargase IV or intramuscularly (IM) on day 1.
- Following recovery from consolidation therapy patients receive 2 sequences of
maintenance therapy with sequence one consisting of vincristine IV on days 1 and 8,
oral prednisone 2-3 times daily on days 1-8, doxorubicin IV on day 15, oral
mercaptopurine 2-3 times daily on days 36-64, oral methotrexate on days 39, 46, 53, and
60, dactinomycin IV on day 85, and methotrexate intrathecally on days 36 and 43.
- At 2 weeks following sequence one of maintenance therapy, patients receive sequence two
consisting of the same regimen as in the first sequence with the addition of
cyclophosphamide IV and carmustine IV on day 15.
- Patients with CNS involvement receive whole brain radiotherapy in addition to
chemotherapy regimens.
Arm II:
- Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22,
and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5,
doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16,
32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27
and continuing until blood counts recover.
- At approximately 3 weeks following induction therapy, patients receive consolidation
therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion
cytarabine on days 1-5, with daunorubicin IV on days 1-3 and methotrexate intrathecally
on days 2 and 4. Patients receive GM-CSF subcutaneously beginning on day 7 and
continuing until blood counts recover.
- At 6-8 weeks following the first course of consolidation therapy, patients receive a
second consolidation course consisting of cytarabine IV bolus on day 1 followed by
continuous infusion cytarabine on days 1-4 with methotrexate IV on days 1-4 and
methotrexate intrathecally on days 2 and 4. Patients receive GM-CSF subcutaneously
beginning on day 6 and continuing until blood counts recover.
- At 6-8 weeks following the second course of consolidation therapy, patients receive a
third consolidation course consisting of pegaspargase IV or IM on day 1.
- At 3-4 weeks following the third course of consolidation therapy, patients receive a
fourth consolidation course consisting of cyclophosphamide IV on day 1.
- At 3 weeks following the completion of consolidation therapy, patients receive the same
maintenance regimen as in Arm I.
Treatment continues in patients achieving complete response. Patients in both arms receive
alternating sequences of maintenance therapy over 2 years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |