Clinical trial · Interventional
S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without peripheral stem cell transplantation in treating Hodgkin's Disease. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkin's disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ABVD x 5 + ABVD x 3
- description
- Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
- interventionNames
- Biological: bleomycin sulfate
- Drug: dacarbazine
- Drug: doxorubicin hydrochloride
- Drug: vinblastine
- type
- EXPERIMENTAL
- label
- ABVD x 5 + ABVD x 1 + HDT + PBSCT
- description
- Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics: * Albumin less than 4.0 mg/dL * Hemoglobin less than 10.5 g/dL * Leukocytosis at least 15,000/mm\^3 * Lymphocytopenia less than 600/mm\^3 or less than 8% of total WBC * Male sex * At least 45 years of age * Stage IV disease * Bidimensionally measurable disease * Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study * Negative chest x-ray within 42 days of study OR * Chest x-ray performed within 28 days of study * Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR * CT scan of thorax, abdomen, and pelvis performed within 28 days of study * No history of lymphoma, myelodyplastic syndrome, or leukemia * No CNS involvement by Hodgkin's disease PATIENT CHARACTERISTICS: Age: * 15 to 65 Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * See Disease Characteristics * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due to liver infiltration by Hodgkin's disease) * Lymphoma-related hepatic dysfunction allowed Renal: * Creatinine no greater than 2.0 times ULN * Creatinine clearance at least 60 mL/min * Lymphoma-related renal dysfunction allowed Cardiovascular: * No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias requiring therapy * Ejection fraction normal * No significant EKG abnormalities suggesting active cardiac disease Pulmonary: * Corrected DLCO at least 60% OR * FEV1 at least 60% predicted Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No HIV or AIDS * No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer * No active bacterial, fungal, or viral infection\* * Afebrile for 3 consecutive days\* NOTE: \*Prior to randomization portion of study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for Hodgkin's disease Surgery: * Not specified Other: * At least 3 days since prior antibiotics, antifungals, or antivirals (except for prophylactic therapy or fever associated with underlying lymphoma) (for randomization portion of study)
References
Publications (0)
Data not yet available