Phase 2
Completed N=25
Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma
Source: ClinicalTrials.gov NCT00574496 ↗Enrolled (actual)
25
Serious AEs
25.0%
Results posted
Sep 2023
Primary outcomePrimary: Progression-free Survival at 1 Year — 33.3 proportion of progression-free pts
Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor stem cell transplant works in treating patients with relapsed or high-risk primary refractory Hodgkin lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival at 1 Year |
33.3 | — |
| SECONDARY Overall Survival |
70.3 | — |
| SECONDARY Disease Relapse or Progression as Measured by CT Scan or PET |
34.3 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed classical Hodgkin lymphoma, including CD20+ disease
- No lymphocyte predominant histology
- Primary refractory or relapsed disease with all 3 risk factors, failed platinum-based chemotherapy, or disease relapsed more than 100 days after autologous stem cell transplantation, proven by biopsy or fine-needle aspiration (cytology) of an involved site
- Risk factors are defined as B-symptoms, extranodal sites of disease, and disease remission lasting 50,000/mm^3
- ANC > 1,000/mm^3
- Cardiac ejection fraction > 50% (for patients ≥ 18 years of age)
- Fractional shortening > 50% by echocardiogram* (for patients 50% on pulmonary function testing*
- Serum creatinine < 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
- Total bilirubin < 2.0 mg/dL in the absence of a history of Gilbert disease
- HIV I and II negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Karnofsky performance status (PS) ≥ 70% or Lansky PS ≥ 70% (for patients proceed to AHSCT)
- No active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold (for patients proceed to AHSCT) NOTE: *measured since last chemotherapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior allogeneic transplantation
- No more than 1 prior autologous transplantation
- No inability to complete planned cytoreduction due to therapy complications
Data sourced from ClinicalTrials.gov (NCT00574496). 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. Informational only — not medical advice.