Clinical trial · Interventional
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
NCT00388349CI-TRIAL-00028116completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease
Conditions
Conditions (3)
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 Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous HCT | Procedure | — | UNRESOLVED |
| Carmustine | Drug | Carmustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Autologous HCT
- description
- Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.
- interventionNames
- Drug: Gemcitabine
- Drug: Vinorelbine
- Drug: Carmustine
- Drug: Etoposide
- Drug: Cyclophosphamide
- Procedure: Autologous HCT
Primary outcomes (1)
- measure
- Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
- timeFrame
- 6 months
- description
- Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible. * Age \< 70 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3. * Phase 1 study component only: 1 or more of the following adverse risk factors * Stage IV extranodal disease at relapse "B" symptoms * Failure to achieve minimal disease with most recent chemotherapy (single lymph nodes \< 2 cm or \>75% reduction in a bulky tumor mass and bone marrow involvement \< 10%) * Progression during induction or salvage therapy * Phase 2 study component only: No risk factor criteria * Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended * Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration * Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control * Pretreatment serum bilirubin \< 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration) * Serum creatinine \< 2 x the institutional ULN (within 28 days prior to registration) * Measured or estimated creatinine clearance \> 60 cc/min by the following formula (within 28 days prior to registration): * Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x creatinine (mg/dL) * Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration) * Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult * Corrected diffusion capacity \> 55% * Written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: * Positive HIV antibody test (must be conducted within 42 days of registration) * No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy * Pregnant * Breast-feeding * Requiring therapy for: * Coronary artery disease * Cardiomyopathy * Dysrhythmia, or * Congestive heart failure * Over age 50 and has received chest irradiation or a total of 300 mg/m\^2 of doxorubicin * History of cardiac disease and the ejection fraction is \< 40% (radionuclide ejection fraction must be within 42 days of registration) * Known allergy to etoposide * History of Grade 3 hemorrhagic cystitis with cyclophosphamide * History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use * No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.
References
Publications (1)
- BACKGROUNDArai S, Letsinger R, Wong RM, Johnston LJ, Laport GG, Lowsky R, Miklos DB, Shizuru JA, Weng WK, Lavori PW, Blume KG, Negrin RS, Horning SJ. Phase I/II trial of GN-BVC, a gemcitabine and vinorelbine-containing conditioning regimen for autologous hematopoietic cell transplantation in recurrent and refractory hodgkin lymphoma. Biol Blood Marrow Transplant. 2010 Aug;16(8):1145-54. doi: 10.1016/j.bbmt.2010.02.022. Epub 2010 Mar 1. PMID 20197102