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Hodgkin's Lymphoma - Relapsed/RefractoryPhase 1/2GEMHDM2014NCT02295722

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

A Phase 1/2 study testing Gemcitabine, Melphalan and ASCT in people with Hodgkin's Lymphoma - Relapsed/Refractory and Non-Hodgkin's Lymphoma - Aggressive, run by AHS Cancer Control Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gemcitabine, Melphalan and ASCT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Apr 2015to Feb 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2

Other trials in Canada

About this study

Official title: Infusional Gemcitabine and High-dose Melphalan (HDM) Conditioning Prior to (ASCT) Autologous Stem Cell Transplantation for Patients With Relapsed/Refractory Lymphoma

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.

Read the detailed description

High-dose chemotherapy with autologous stem cell transplantation is the current standard of care for patients with chemosensitive relapsed Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma, and is an established effective therapy for patients with relapsed follicular lymphoma. Disease relapse remains a major problem, occurring in 50% of these patients, particularly in patients with primary refractory disease or other high-risk features. The addition of gemcitabine to single-agent melphalan as a high-dose conditioning regimen presents a promising combination that may lead to improvements in EFS (Event free survival). If this trial gives encouraging results, it may lead to a phase III trial evaluating this treatment strategy.

Drug exposure would be AUC (area under curve) and clinical factors would be things like obesity, renal function, disease characteristics.

We would be looking at the safety outcomes - i.e. adverse events as a measure of safety and tolerability. The adverse events would be non-hematological toxicities (any) and whether or not it is related to AUC. AUC in relationship to PFS (progression free survival) is also important (we want to know if we need to adjust dose to improve PFS).

Being tested
Gemcitabine, Melphalan, ASCT
Keywords
eligible for high-dose therapy and stem cell transplantation
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    gemcitabine 1.5 g/m2 INFUSED

  • MelphalanDrug

    200 mg/m2

  • ASCTOther

    Day 0 - Stem cell infusion

Study groups in NCT02295722
Study groupRoleWhat they receive
Gemcitabine/Melphalan Condition + ASCTExperimentalDay -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.
Receives: Drug: Gemcitabine; Drug: Melphalan; Other: ASCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 YEARS

Secondary outcomes (6)

  1. Overall survival

    The goal of this study is to improve overall 3-year PFS rate by 15% with the melphalan gemcitabine conditioning.

    Measured: 3 Years

  2. Cost Effectiveness

    Cost-effectiveness as measured by in-hospital costs of Gemcitabine-Melphalan relative to historical controls treated in Calgary with BEAM or Melphalan+/-TBI (Total Body Irradiation).

    Measured: 3 Years

  3. Measure of Melphalan pharmacokinetics, AUC (area under curve)

    Drug exposure would be AUC (area under curve) . Once the dose of gemcitabine has been established, all subsequent patients will receive a uniform HDCT (high dose chemotherapy) regimen. Patients will undergo blood draws for pharmacokinetic testing at the following time points relative to the end of melphalan infusion: 5 minutes, 30 minutes, 1 hour, 3 hours, 5 hours, 7-10 hours, and 18-23 hours. Samples will be processed at the local pharmacokinetics laboratory in Calgary

    Measured: 3 Years

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

    The number of patients with adverse events as a measure of safety and tolerability.

    Measured: 3 years

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

    Drug exposure as measured by area under the curve related to number of patients with adverse events (non-hematological toxicity) and progression-free survival

    Measured: 3 years

  6. Safety Outcomes assessed adverse events as a measure of safety and tolerability

    Assess adverse events as a measure of safety and tolerability. The adverse events would be non-hematological toxicities (any) and whether or not it is related to AUC. AUC in relationship to PFS is also important (we want to know if we need to adjust dose to improve PFS).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2023
  4. Study completionFeb 2023

Why it stopped: It did not show a significant benefit to justify completing the full target accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02295722
Sponsor's protocol ID
GEMHDM2014
Acronym
GEMHDM2014
Status last verified
Jul 2024
First submitted
30 Oct 2014
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gemcitabine, Melphalan and ASCT in people with Hodgkin's Lymphoma - Relapsed/Refractory and Non-Hodgkin's Lymphoma - Aggressive, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: It did not show a significant benefit to justify completing the full target accrual.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival of relapsed/refractory lymphoma patients treated with infusional gemcitabine, high dose melphalan (Gem-Mel) and ASCT (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02295722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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