Clinical trial · Interventional
GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma
Infusional Gemcitabine and High-dose Melphalan (HDM) Conditioning Prior to (ASCT) Autologous Stem Cell Transplantation for Patients With Relapsed/Refractory Lymphoma
NCT02295722CI-TRIAL-00078612GEMHDM2014terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It did not show a significant benefit to justify completing the full target accrual.
Summary
Brief summary (as posted)
Objective of study: To evaluate the safety and efficacy of infusional gemcitabine prior to HDM (high-dose melphalan) as HDCT (High Dose Chemotherapy) followed by autologous stem cell transplantation in patients with relapsed/refractory lymphoma.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Hodgkin's Lymphoma - Relapsed/Refractory | — | UNRESOLVED | — |
| Non-Hodgkin's Lymphoma - Aggressive | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASCT | Other | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Melphalan Condition + ASCT
- description
- Day -1 - * IV gemcitabine 1.5-2.5 g/m2 (depending on dose level assigned) administered as a loading bolus of 75 mg/m2, followed by a continuous infusion of 10 mg/m2/min. * immediately following gemcitabine - IV melphalan 200 mg/m2 over 5 minutes. Day 0 •Stem cell infusion Patients will be assigned a dose level using the continual reassessment method based on the toxicity data available at the time of their enrollment. The dosing will start at 1.5 g/m2 and will increase by 0.5 mg/m2 at each level to a maximum of 2.5 g/m2. Dose-limiting toxicity is defined as grade 3 mucositis or skin toxicity lasting more than 3 days before downgrading, or any grade 4 non-hematological toxicity.
- interventionNames
- Drug: Gemcitabine
- Drug: Melphalan
- Other: ASCT
Primary outcomes (2)
- measure
- Progression free survival of relapsed/refractory lymphoma patients treated with infusional gemcitabine, high dose melphalan (Gem-Mel) and ASCT
- timeFrame
- 3 years
- description
- The goal is to improve overall 3-year PFS by 15% over what would be expected with standard conditioning regimens. Patients will be stratified into 3 groups according to disease: (a) relapsed/refractory Hodgkins's lymphoma, (b) relapsed/refractory aggressive non-Hodgkin's lymphoma, and (c) relapsed/refractory follicular lymphoma. Grade 3-4 non-hematological toxicity will be defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to provide written informed consent 2. Age over 18 years 3. Relapsed/refractory lymphoma after at least 1 prior chemotherapy treatment: 1. Hodgkin's lymphoma 2. Aggressive non-Hodgkin's lymphoma 3. Follicular lymphoma 4. Chemosensitive disease at time of transplantation (i.e. partial response or better to salvage chemotherapy) 5. ECOG (Eastern Cooperative Oncology Group) performance 0-2 6. Adequate organ function: 1. Cardiac: LVEF (left ventricular ejection fraction)\>40% 2. Pulmonary: FEV1 (forced expiratory volume at one second) and DLCO (diffusing capacity of lung for carbon monoxide)\>60% predicted 3. Renal: creatinine \<150 µmol/L unless caused by ureteric obstruction from lymphoma 4. Liver: No evidence of cirrhosis. ALT (Alanine Aminotransferase) and bilirubin \<2x upper limit of normal unless caused by biliary tract obstruction from lymphoma Exclusion Criteria: 1. Clinically significant active infection 2. Active secondary central nervous system disease 3. Other serious co-morbid illness that would compromise study participation. 4. Pregnant or lactating females 5. Prior HDCT/ASCT
References
Publications (0)
Data not yet available
No reference posted for this study.