GEMHDM2014 : Gem-HDM HDT and ASCT for Relapsed/ Refractory Lymphoma

NCT02295722 | Terminated Phase 1

• 1 other identifier: GEMHDM2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hodgkin's Lymphoma - Relapsed/Refractory; Non-Hodgkin's Lymphoma - Aggressive; Follicular Lymphoma

Keywords

eligible for high-dose therapy and stem cell transplantation

Outcome Measures

Primary Outcomes (2)

• Progression free survival of relapsed/refractory lymphoma patients treated with infusional gemcitabine, high dose melphalan (Gem-Mel) and ASCT

  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.

  3 years

• Grade 3-4 Hematological Toxicity

  Assessment of 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.

  3 YEARS

Secondary Outcomes (6)

• Overall survival

  3 Years

• Cost Effectiveness

  3 Years

• Measure of Melphalan pharmacokinetics, AUC (area under curve)

  3 Years

• Evaluation of relationship between clinical factors and drug exposure in treatment of Gemcitabine/Melphalan with ASCT (autologous stem cell transplantation)

  3 years

• Evaluation of relation between drug exposure and non-hematological toxicity and progression free survival

  3 years

Study Arms (1)

Gemcitabine/Melphalan Condition + ASCT

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Melphalan; Other: ASCT

Interventions

Gemcitabine DRUG

gemcitabine 1.5 g/m2 INFUSED

Gemcitabine/Melphalan Condition + ASCT

Melphalan DRUG

200 mg/m2

Gemcitabine/Melphalan Condition + ASCT

ASCT OTHER

Day 0 - Stem cell infusion

Gemcitabine/Melphalan Condition + ASCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent
• Age over 18 years
• Relapsed/refractory lymphoma after at least 1 prior chemotherapy treatment:
• Hodgkin's lymphoma
• Aggressive non-Hodgkin's lymphoma
• Follicular lymphoma
• Chemosensitive disease at time of transplantation (i.e. partial response or better to salvage chemotherapy)
• ECOG (Eastern Cooperative Oncology Group) performance 0-2
• Adequate organ function:
• Cardiac: LVEF (left ventricular ejection fraction)\>40%
• Pulmonary: FEV1 (forced expiratory volume at one second) and DLCO (diffusing capacity of lung for carbon monoxide)\>60% predicted
• Renal: creatinine \<150 µmol/L unless caused by ureteric obstruction from lymphoma
• Liver: No evidence of cirrhosis. ALT (Alanine Aminotransferase) and bilirubin \<2x upper limit of normal unless caused by biliary tract obstruction from lymphoma

You may not qualify if:

• Clinically significant active infection
• Active secondary central nervous system disease
• Other serious co-morbid illness that would compromise study participation.
• Pregnant or lactating females
• Prior HDCT/ASCT

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Tom Baker Cancer Centre: collaborator

Study Sites (1)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Gemcitabine; Melphalan

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• MONA SHAFEY, MD

  Tom Baker Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 20, 2014
• Study Start: April 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)