Phase 2
N=42
Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00265889 ↗Enrolled (actual)
42
Serious AEs
2.7%
Results posted
Aug 2013
Primary outcome: Primary: Progression-free Survival — 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); busulfan (Drug); cyclophosphamide (Drug); etoposide (Drug); melphalan (Drug); autologous-autologous tandem hematopoietic stem cell transplantation (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
18 | — |
| PRIMARY Response Rate |
18; 14; 2; 3; 0 | — |
| PRIMARY Number of Patients That Experience Pulmonary Toxicity |
9 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00265889). 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.