Clinical trial · Interventional
Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma
- 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 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.
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 (19)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| mechlorethamine hydrochloride | Drug | Mechlorethamine |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Risk or Relapsed Hodgkin Lymphoma
- description
- This is a phase 2 intention-to-treat study of salvage chemotherapy followed by allogeneic HSC transplant for the treatment of primary refractory or relapsed HL. Patients who 1) do not progress on salvage chemotherapy, and 2) have both suitable HSC donors and 3) a satisfactory pre-allograft work-up will proceed to allograft. Patients who fail any of these 3 criteria will be off-study and considered treatment failures for the purposes of the intention-to-treat study.
- interventionNames
- Drug: cyclophosphamide
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Drug: gemcitabine hydrochloride
- Drug: ifosfamide
- Drug: mechlorethamine hydrochloride
- Drug: melphalan
- Drug: methotrexate
- Drug: mycophenolate mofetil
- Drug: prednisone
- Drug: procarbazine hydrochloride
- Drug: vincristine sulfate
- Drug: vinorelbine tartrate
- Procedure: allogeneic bone marrow transplantation
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 \< 1 year after first-line therapy
* Failed doxorubicin hydrochloride or mechlorethamine hydrochloride-containing front-line therapy
* Fludeoxyglucose F 18-PET scan demonstrating PET-avid disease
* No more than 2 prior salvage chemotherapy regimens (for patients proceed to allogeneic hematopoietic stem cell transplantation \[AHSCT\])
* Donor available meeting 1 of the following criteria (for patients proceed to AHSCT):
* HLA-matched or one allele mismatched related donor
* Genotypically or phenotypically matched at ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution
* Peripheral blood stem cells (PBSC) collected
* HLA-matched unrelated donor
* Matched at ≥ 9/10 (allele mismatch only) of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution
* PBSC or bone marrow collected
* Umbilical cord blood (2 units)
* must be ≥ 4/6 HLA-A, B antigen, and DRB1 allele matched with recipient
PATIENT CHARACTERISTICS:
* Platelet count \> 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 \< 18 years of age)
* Adjusted diffusing capacity \> 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 complicationsReferences
Publications (0)
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