Clinical trial · Interventional
Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
NCT00265889CI-TRIAL-00012693completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Poor Risk
- description
- Primary progressive, recurrent, or resistant relapse patients
- interventionNames
- Biological: filgrastim
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Good Risk
- description
- First recurrence patients
- interventionNames
- Biological: filgrastim
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: melphalan
- Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically\* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria: * Disease progression during initial first line chemotherapy * Complete response lasting ≤ 90 days after induction * Partial response lasting ≤ 90 days after induction * First recurrence/progression with the duration of initial response ≤ 12 months after completion of chemotherapy NOTE: \*There must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression * No clonal abnormalities in marrow collection * Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection * Must have adequate sections of original diagnostic specimen available for review * Needle aspirations or cytologies are not adequate * No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5 years) * No CNS involvement PATIENT CHARACTERISTICS: Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.5 times upper limit of normal\* (ULN) NOTE: \*Unless due to Hodgkin's lymphoma Renal * Creatinine clearance ≥ 60 mL/min * Creatinine ≤ 2.0 times ULN Cardiovascular * Ejection fraction ≥ 45% by 2-D echocardiogram * No significant active cardiac disease Pulmonary * Adequate pulmonary function * DLCO ≥ 45% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No known HIV or AIDS infection * No active bacterial, fungal, or viral infection * No medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics Surgery * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.