Non-Hodgkins LymphomaPhase 1/2NCT00807196
Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma
A Phase 1/2 study testing Rituximab, 90Y ibritumomab tiuxetan (Zevalin) and Cyclophosphamide in people with Non-Hodgkins Lymphoma, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkins Lymphoma
- What is being tested?
- Rituximab, 90Y ibritumomab tiuxetan (Zevalin) and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Dec 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have/be
- Age 18 to 65 years. Patients between age 66 and 69 may be enrolled if judged to be in excellent physical condition as per treating physician and study investigator and based on institutional practice.
- Diagnosis of Non-Hodgkin lymphoma, follicular, marginal zone, small lymphocytic lymphoma, mantle cell lymphoma or transformed from an indolent NHL to aggressive histology disease lymphoma as defined by the World Health Organization.
- Disease relapsed after, refractory or failing to achieve a PR after two or more cycles of intensive salvage chemotherapy (R-ESHAP or other) or disease relapsed after autologous stem cell transplantation. Poor partial response is defined as less than 50% reduction of tumor size. Salvage chemotherapy has to be administered after either 1st, 2nd or 3rd relapse
- Disease expressing the CD 20 antigen
- ECOG performance status 0-2
Show all 9Show fewer
- Judged to be able to tolerate NST and Zevalin treatment based on institutional criteria.
- Signed written informed consent
- At least one fully HLA matched sibling without evident contraindications to the donation procedures and willing to sign consent for donation
Who cannot join
- Patients must not have/be
- Abnormal renal function (creatinine > 1.5 x upper limit of normal (ULN)
- Abnormal hepatic function (bilirubin > 2 x ULN, ALT/AST>2x ULN)
- Cardiac ejection fraction <40% and/or other significant cardiac compromise
- Severe defects in pulmonary function tests or receiving continuous oxygen
- Severe concurrent illness, such as symptomatic congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder or known HIV positive
Show all 16Show fewer
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) that may impact on patients life expectancy or any cancer curatively treated < 3 years prior to study entry.
- History of prior allogeneic bone marrow transplant
- Evidence of active hepatitis B or C infection or positivity for hepatitis-B surface antigen
- Known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy or a history or presence of human anti-mouse antibodies (HAMA)
- A female patient who is pregnant or breast feeding and an adult of reproductive potential who is not employing an effective method of birth control during the study.
- CNS lymphoma
- Ongoing confirmed or suspected significant infection
- Prior treatment with radioimmunotherapy
- Other condition preventing participation in standard NST
- No fully matched sibling donor
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H2V 1W7
Thomas Kiss, MD, (514)252-3404, thomas.kiss@umontreal.ca
Dominique Beaupré, BSc nursing, (514)252-3400 ext. 5605, dbeaupré.hmr@ssss.gouv.qc.ca
About this study
Official title: Phase I-II Non-Randomized Study of Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Indolent Non Hodgkin Lymphoma
The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant.
Read the detailed description
Despite initial high response rates of low grade Non Hodgkin lymphoma, progressive or refractory disease currently remains incurable. Being a radiosensitive tumor, we hypothesize that combining different modalities of treatment including targeted radioimmunotherapy (RIT), and a graft versus lymphoma effect related to an allogeneic non myeloablative stem cell transplant may increase response and survival rates in a safe manner in patients with persistent disease following initial treatment. In this study patients who are not eligible for a standard stem cell transplant approach because of relapsed or refractory disease and who have a related sibling donor are treated with RIT followed by an allogeneic non myeloablative blood stem cell transplant
- Conditions
- Non-Hodgkins Lymphoma
- Being tested
- Rituximab, 90Y ibritumomab tiuxetan (Zevalin), Cyclophosphamide, Fludarabine, Non myeloablative allogeneic stem cell transplantation
- Keywords
- Allogeneic Stem Cell Transplantation, Zevalin, Non-Hodgkins Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
250mg/m2 day -21 and day -14 of preparative regimen
90Y ibritumomab tiuxetan (Zevalin)Drug
0.4 mCi/kg IV on day -14 of preparative regimen
CyclophosphamideDrug
300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
FludarabineDrug
30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen
Non myeloablative allogeneic stem cell transplantationOther
Blood stem cell infusion on day 0
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | Not described Receives: Drug: Rituximab; Drug: 90Y ibritumomab tiuxetan (Zevalin); Drug: Cyclophosphamide; Drug: Fludarabine; Other: Non myeloablative allogeneic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD
Measured: one year
Secondary outcomes (1)
Overall response rate, overall and disease free survival
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkins LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Thomas Kiss, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807196
- Sponsor's protocol ID
- ZEV0701
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Non-Randomized Study of Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Indolent Non Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00807196
- Acronym / sponsor ID
- ZEV0701
- Conditions
- Non-Hodgkins Lymphoma
- Keywords
- Allogeneic Stem Cell Transplantation, Zevalin, Non-Hodgkins Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the ability to combine a radioactive medication directly targeted against lymphoma cells with the immune effects of an allogeneic blood stem cell transplant.
Detailed description
Despite initial high response rates of low grade Non Hodgkin lymphoma, progressive or refractory disease currently remains incurable. Being a radiosensitive tumor, we hypothesize that combining different modalities of treatment including targeted radioimmunotherapy (RIT), and a graft versus lymphoma effect related to an allogeneic non myeloablative stem cell transplant may increase response and survival rates in a safe manner in patients with persistent disease following initial treatment. In this study patients who are not eligible for a standard stem cell transplant approach because of relapsed or refractory disease and who have a related sibling donor are treated with RIT followed by an allogeneic non myeloablative blood stem cell transplant
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Drug: Rituximab, Drug: 90Y ibritumomab tiuxetan (Zevalin), Drug: Cyclophosphamide, Drug: Fludarabine, Other: Non myeloablative allogeneic stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have/be
- Age 18 to 65 years. Patients between age 66 and 69 may be enrolled if judged to be in excellent physical condition as per treating physician and study investigator and based on institutional practice.
- Diagnosis of Non-Hodgkin lymphoma, follicular, marginal zone, small lymphocytic lymphoma, mantle cell lymphoma or transformed from an indolent NHL to aggressive histology disease lymphoma as defined by the World Health Organization.
- Disease relapsed after, refractory or failing to achieve a PR after two or more cycles of intensive salvage chemotherapy (R-ESHAP or other) or disease relapsed after autologous stem cell transplantation. Poor partial response is defined as less than 50% reduction of tumor size. Salvage chemotherapy has to be administered after either 1st, 2nd or 3rd relapse
- Disease expressing the CD 20 antigen
Key exclusion criteria (16 listed)
- Patients must not have/be
- Abnormal renal function (creatinine > 1.5 x upper limit of normal (ULN)
- Abnormal hepatic function (bilirubin > 2 x ULN, ALT/AST>2x ULN)
- Cardiac ejection fraction <40% and/or other significant cardiac compromise
- Severe defects in pulmonary function tests or receiving continuous oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab250mg/m2 day -21 and day -14 of preparative regimen | Drug | T |
| 90Y ibritumomab tiuxetan (Zevalin)0.4 mCi/kg IV on day -14 of preparative regimen | Drug | T |
| Cyclophosphamide300mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen | Drug | T |
| Fludarabine30mg/m2 IV daily for 5 days day -8 to day -4 of preparative regimen | Drug | T |
| Non myeloablative allogeneic stem cell transplantationBlood stem cell infusion on day 0 | Other | T |
Primary outcome
Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD
Time frame: one year
1 secondary outcome
Overall response rate, overall and disease free survival
Time frame: 360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2008.
Related trials for Non-Hodgkins Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kiss, MD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituximab, 90Y ibritumomab tiuxetan (Zevalin) and Cyclophosphamide in people with Non-Hodgkins Lymphoma, run by Maisonneuve-Rosemont Hospital 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Dec 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Kiss, MD (514-252-3404, thomas.kiss@umomtreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment, chimerism, transplant related toxicity, acute and chronic GVHD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2008.