N/A
N=174
High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Myeloid Leukemia in Remission · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q) · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Bottom Line
View on ClinicalTrials.gov: NCT00536601 ↗Enrolled (actual)
174
Serious AEs
36.2%
Results posted
Apr 2021
Primary outcome: Primary: Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) — 33; 14; 22; 43 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etoposide (Drug); cyclophosphamide (Drug); carmustine (Drug); melphalan (Drug); busulfan (Drug); carboplatin (Drug); thiotepa (Drug); total-body irradiation (Radiation); autologous hematopoietic stem cell transplantation (Procedure); autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) |
33; 14; 22; 43; 37; 0 | — |
| SECONDARY Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) |
1; 9; 19; 31; 3 | — |
| SECONDARY Response Rate (Complete Remission) |
5; 17; 54; 17; 7 | — |
| SECONDARY Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) |
33; 61; 45; 39; 46 | — |
Summary
This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
- Recurrent or refractory disease or disease at high risk for recurrence
- Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
- Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
- Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
- Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
- Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
- Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
- Amyloidosis: primary or previously treated
- Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
- Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
- Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
- Life expectancy > 2 months
- Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
- Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram
- Bilirubin 1500/uL
- Platelet (Plt) > 75,000/uL
- Prior to stem cell storage:
- No radiation within three weeks before stem cell harvest
- Bone marrow may be used in conjunction with blood progenitor cells
- Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number 65 years
- No compatible donor identified
- Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT
- Adequate bone marrow or blood stem cell dose obtained:
- For blood stem cells: total CD 34+ >= 2 x 10^6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of >= l x 10^8/kg
Data sourced from ClinicalTrials.gov (NCT00536601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.