Clinical trial · Interventional
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease
- 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)
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
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 |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Stem Cell Infusion | Procedure | — | UNRESOLVED |
| Antithymocyte Globulin | Drug | — | UNRESOLVED |
| Filgrastim (G-CSF) | Drug | Filgrastim | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Fludarabine + Melphalan
- description
- Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes for one day; Fludarabine 33 mg/m\^2 IV for 4 days; Melphalan 70 mg/m\^2 IV over 30 minutes for 2 days. Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation. If receiving transplant from matched unrelated donor (not blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant, infusion of stem cells on Day 0. Tacrolimus 0.03 mg/kg by vein over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
- interventionNames
- Drug: Gemcitabine
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Antithymocyte Globulin
- Procedure: Allogeneic Stem Cell Infusion
- Drug: Tacrolimus
- Drug: Filgrastim (G-CSF)
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Fludarabine + Melphalan
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients \< 65 years of age with histologically confirmed refractory or relapsed Hodgkin's disease (including patients who fail or relapse after autologous SCT). This upper age limit will apply to transplants from both matched related and unrelated donors.
2. Patients should have any of the following disease status: a. responsive or stable disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e. not rapidly progressive) relapses.
3. Patients must have a serum bilirubin equal to or \</=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or \</= 3 times the upper limit of the normal range, serum creatinine \<2.0 mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no symptomatic cardiac or pulmonary disease and a performance status equal to or \</=2. Left ventricular ejection fraction \>/= 40%, forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% predicted.
4. Patients must have an HLA-compatible related or unrelated donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8 of 8 match") is required.
5. Women of childbearing potential must have a negative serum pregnancy test within two weeks of study entry and should be advised to avoid becoming pregnant. Men should be advised to not father a child while on treatment. Both women of childbearing potential and men must agree to practice effective methods of contraception.
6. Patients must be capable and willing to sign informed consent.
Exclusion Criteria:
1. Patients with documented disease progression on salvage chemotherapy.
2. Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
3. Severe concomitant medical or psychiatric illness.
4. Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.
5. Chronic active hepatitis or cirrhosis.
6. Active or uncontrolled infection.
7. Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e., small or large bowel) completed within 10 weeks of transplant admission. Radiation therapy shortly before the start of the preparative regimen is allowed.
8. Prior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent \< 5 years previously will not be allowed unless approved by the Protocol Chair. Cancer treated with curative intent \> 5 years previously will be allowed.References
Publications (0)
Data not yet available