Clinical trial · Interventional
Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)
Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lower than anticipated accrual
Summary
Brief summary (as posted)
This study is designed as a Phase II/III, multi-center trial, comparing two transplant strategies to determine whether non-myeloablative allogeneic Hematopoietic Stem Cell Transplantation (HSCT) will improve long-term progression-free survival compared to autologous HSCT. Recipients will be biologically assigned to the appropriate treatment arm depending on the availability of a Human Leukocyte Antigen (HLA) matched sibling.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic transplant | Procedure | — | UNRESOLVED |
| Autologous transplant | Procedure | — | UNRESOLVED |
| Chemotherapy or Radiation therapy | Radiation | — | UNRESOLVED |
| Cyclophosphamide and Rituximab | Drug | — | UNRESOLVED |
| Filgrastim | Drug | Filgrastim | ALIAS |
| GVHD Prophylaxis | Drug | — | UNRESOLVED |
| Non-myeloablative Conditioning regimen | Drug | — | UNRESOLVED |
| Rituximab maintenance therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Autologous Transplant
- description
- Cyclophosphamide and Rituximab with Filgrastim conditioning and chemotherapy or radiation therapy prior to autologous Hematopoietic Stem Cell Transplant (HSCT). Rituximab maintenance therapy following HSCT.
- interventionNames
- Drug: Cyclophosphamide and Rituximab
- Drug: Filgrastim
- Radiation: Chemotherapy or Radiation therapy
- Procedure: Autologous transplant
- Drug: Rituximab maintenance therapy
- type
- ACTIVE_COMPARATOR
- label
- Allogeneic Transplant
- description
- Non-myeloablative conditioning regimen followed by allogeneic Hematopoietic Stem Cell Transplant (HSCT). Graft-versus-Host Disease (GVHD) Prophylaxis therapy following HSCT.
- interventionNames
- Drug: Cyclophosphamide and Rituximab
- Drug: Filgrastim
- Drug: Non-myeloablative Conditioning regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
Initial Patient Inclusion Criteria:
* Histologically confirmed recurrent Revised European American Lymphoma (REAL) classification follicle center lymphoma, follicular grades I and II, OR histologically confirmed World Health Organization (WHO) classification follicular lymphoma grades 1, 2, 3a or 3b; for either classification, the diffuse component or presence of large cleaved cells (if present) cannot be more than 50% of high power field; patients do not have to express t(14;18) to be eligible
* Received three or fewer prior regimens of chemotherapy; monoclonal antibody therapy and involved field radiation therapy will not be counted as a prior therapy
* Beyond first Complete Remission (CR) or first Partial Remission (PR) AND demonstrate chemosensitive disease; chemosensitive disease will be defined as less than 20% bone marrow involvement in the aspirate or core biopsy with follicular lymphoma AND lymph node size in axial diameter of less than 3 cm or a greater than 50% reduction in estimated lymph node volume to be measured as product of bi-dimensional measurements; Positron Emission Tomography (PET) scanning will not be used for staging or response purposes
* Patients with adequate organ function as measured by:
1. Cardiac: left ventricular ejection fraction at rest at least 45%
2. Hepatic: bilirubin less than 2 times the upper limit of normal and alanine transaminase (ALT) and aspartate aminotransferase (AST) less than 3 times the upper limit of normal
3. Renal: creatinine clearance greater than 40 mL/min
4. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), Forced expiratory volume in one second (FEV1), and Forced vital capacity (FVC) greater than 50% of predicted (corrected for hemoglobin)
* If the patient is younger than 18 years of age and they have reached the age of assent, then they must have completed the local Institutional Review Board (IRB) assent process.
* Able to receive cyclophosphamide and rituximab mobilization chemotherapy no earlier than 3 weeks from the beginning of the most recent cycle of salvage chemotherapy and no later than 6 weeks from enrollment
Patient Inclusion Criteria for Proceeding to Hematopoietic Stem Cell Transplant (HSCT):
* Collection of an autologous or allogeneic graft of at least 2.0 \* 10\^6 CD34+ cells/kg
* Blood count recovery defined as Absolute Neutrophil Count (ANC) greater than 1000/mm3 and platelets greater than 100 \* 10\^9/L
Patient Inclusion Criteria for Maintenance Therapy:
* Liver and renal function tests within the inclusion criteria for initial autograft
* Off intravenous antibiotics and off amphotericin B formulations for proven, probable or possible fungal infections
* No active Cytomegalovirus (CMV) infections or for patients with CMV infection post-autograft, treated with ganciclovir, valganciclovir, or foscarnet per institutional guidelines and CMV antigenemia negative
* Mucositis resolved and off hyperalimentation
Exclusion Criteria:
* Karnofsky performance score less than 70%
* Follicular lymphoma that show histologic evidence of transformation
* Uncontrolled hypertension
* Patients with uncontrolled bacterial, viral or fungal infection (currently taking medication and progression without clinical improvement).
* Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent more than 5 years previously will be reviewed on a case-by-case basis by a Protocol Chair or Medical Monitor.
* Pregnant (positive Beta Human chorionic gonadotropin (β-HCG)) or breastfeeding
* Seropositive for Human immunodeficiency virus (HIV)
* Unwilling to use contraceptive techniques during treatment
* Prior autologous or allogeneic HSCT
* Known anaphylactic reaction to rituximabReferences
Publications (1)
- RESULTTomblyn MR, Ewell M, Bredeson C, Kahl BS, Goodman SA, Horowitz MM, Vose JM, Negrin RS, Laport GG. Autologous versus reduced-intensity allogeneic hematopoietic cell transplantation for patients with chemosensitive follicular non-Hodgkin lymphoma beyond first complete response or first partial response. Biol Blood Marrow Transplant. 2011 Jul;17(7):1051-7. doi: 10.1016/j.bbmt.2010.11.004. Epub 2010 Nov 10. PMID 21073974