Hodgkin DiseasePhase 2NCT00478959
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
A Phase 2 study testing Lenalidomide (Revlimid®) in people with Hodgkin Disease, run by University Health Network, Toronto.
Trial summary
This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Lenalidomide (Revlimid®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2014
- Phase
- Phase 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
- Histologically confirmed Hodgkin's lymphoma that is relapsed or refractory (repeat biopsy is not mandatory) and is no longer eligible for curative treatment
- </=3 prior chemotherapy regimens (in patients without a prior ASCT)
- Patients with disease progression after ASCT will be eligible if they have received </= 1 additional chemotherapy regimen post-ASCT
- ECOG Performance Status 0-2
- Adequate hematological function:
- Absolute granulocyte count > 1.0 x 10 to the 9/L
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- Platelet count > 75 x 10 to the 9/L
- Adequate renal and hepatic functions:
- Serum creatinine < 1.25 x UNL or a calculated creatinine clearance > 50 mL/min
- Serum bilirubin < 1.5 x UNL and AST/ALT < 3 x UNL
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. (See Appendix B Pregnancy Testing Guidelines and Acceptable Birth Control Methods.)
- Able to take aspirin (325 mg daily) as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
- Written Informed Consent must be given according to ICH/GCP and national/local regulations
Who cannot join
- Prior treatment with Lenalidomide or Thalidomide
- Use of any other experimental therapy within the 28 days prior to baseline assessment
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C
- Pregnant or Lactating women
- Other significant medical problems such as uncontrolled hypertension, uncontrolled psychiatric symptoms disorders, serious infections, active peptic ulcer disease, or any other medical conditions that might be aggravated by treatment
- Second malignancy in the past five years with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
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- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Concurrent use of other anti-cancer agents or treatments.
About this study
This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
Read the detailed description
While the results of primary therapy for Hodgkin's lymphoma are generally excellent, between 10-20% of patients with advanced stage disease will not enter a complete remission (CR) and between 20-30% of patients will relapse after completion of treatment. Salvage chemotherapy followed by high dose chemotherapy and autologous stem cell transplantation (ASCT) has become the treatment of choice in patients with relapsed or initially chemotherapy-refractory disease.
Although high dose chemotherapy remains a curative option for the treatment of relapsed or chemotherapy-refractory Hodgkin's lymphoma, up to 50% of patients will ultimately recur post-stem cell transplant and will require further treatment.
Thalidomide is an agent that has anti-inflammatory, immunomodulatory and anti-angiogenic properties. Thalidomide has been shown to have activity in a number of solid and hematologic malignancies, and has demonstrated effectiveness in the treatment of refractory multiple myeloma. A dose escalation study of single-agent thalidomide has been performed in heavily pre-treated patients in which two Hodgkin's patients were enrolled and did not respond to treatment. Based on the NCI experience with vinblastine, we initiated a phase II trial examining the combination of thalidomide and vinblastine in patients who were being treated palliatively for Hodgkin's lymphoma. In a heavily pre-treated group of patients (70% of cases having relapsed post-ASCT), a response rate of 40% to the combination was noted with median duration of response of over nine months.
Lenalidomide (Revlimid®) is a thalidomide derivative and the first-in-class novel immunomodulatory agent that has more potent activity as well as a more favourable toxicity profile than the parent compound. Based on the alterations demonstrated in various cytokines and angiogenic markers in patients with Hodgkin's lymphoma, we feel that Lenalidomide's immunomodulatory and anti-angiogenic effects make this an ideal drug to study in this lymphoma. This will be the first study to assess Lenalidomide in patients with Hodgkin's lymphoma.This is a single arm, open-label phase II multi-centre study evaluating the single agent activity of Lenalidomide in relapsed or refractory Hodgkin's lymphoma. The primary endpoint is objective response rate (CR + CRu + PR) as determined by International Workshop Criteria.
Initial treatment will consist of lenalidomide 25 mg PO daily given for 21 consecutive days (days 1 - 21), with seven days off on a 28 day cycle.Patients with PR, CR or CRu, may continue on therapy for 2 cycles past best response.Patients with PD at any time or those with evidence of SD after cycle 4 of monotherapy will be eligible to receive treatment with dexamethasone 40 mg PO daily on days 1 - 4 and 15 - 18 of a 28 day cycle while continuing protocol treatment if they continue to meet the criteria of continuation on therapy.
- Conditions
- Hodgkin Disease
- Being tested
- Lenalidomide (Revlimid®)
- Keywords
- Lenalidomide, Revlimid, Hodgkin's, Hodgkin, Hodgkin's Lymphoma, Hodgkin's Disease, Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide (Revlimid®)Drug
Also called Revlimid
25mg PO daily for 21 out of 28days per cycle
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma. Receives: Drug: Lenalidomide (Revlimid®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate (CR + CRu + PR) of Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma
Measured: CT scans performed every two months while on therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- John Kuruvilla, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478959
- Sponsor's protocol ID
- CC-5013-HL
- Status last verified
- Sep 2020
- First submitted
- 24 May 2007
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00478959
- Acronym / sponsor ID
- CC-5013-HL
- Conditions
- Hodgkin Disease
- Keywords
- Lenalidomide, Revlimid, Hodgkin's, Hodgkin, Hodgkin's Lymphoma, Hodgkin's Disease, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Dec 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 May 2007 (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.
This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
Detailed description
While the results of primary therapy for Hodgkin's lymphoma are generally excellent, between 10-20% of patients with advanced stage disease will not enter a complete remission (CR) and between 20-30% of patients will relapse after completion of treatment. Salvage chemotherapy followed by high dose chemotherapy and autologous stem cell transplantation (ASCT) has become the treatment of choice in patients with relapsed or initially chemotherapy-refractory disease.
Although high dose chemotherapy remains a curative option for the treatment of relapsed or chemotherapy-refractory Hodgkin's lymphoma, up to 50% of patients will ultimately recur post-stem cell transplant and will require further treatment.
Thalidomide is an agent that has anti-inflammatory, immunomodulatory and anti-angiogenic properties. Thalidomide has been shown to have activity in a number of solid and hematologic malignancies, and has demonstrated effectiveness in the treatment of refractory multiple myeloma. A dose escalation study of single-agent thalidomide has been performed in heavily pre-treated patients in which two Hodgkin's patients were enrolled and did not respond to treatment. Based on the NCI experience with vinblastine, we initiated a phase II trial examining the combination of thalidomide and vinblastine in patients who were being treated palliatively for Hodgkin's lymphoma. In a heavily pre-treated group of patients (70% of cases having relapsed post-ASCT), a response rate of 40% to the combination was noted with median duration of response of over nine months.
Lenalidomide (Revlimid®) is a thalidomide derivative and the first-in-class novel immunomodulatory agent that has more potent activity as well as a more favourable toxicity profile than the parent compound. Based on the alterations demonstrated in various cytokines and angiogenic markers in patients with Hodgkin's lymphoma, we feel that Lenalidomide's immunomodulatory and anti-angiogenic effects make this an ideal drug to study in this lymphoma. This will be the first study to assess Lenalidomide in patients with Hodgkin's lymphoma.This is a single arm, open-label phase II multi-centre study evaluating the single agent activity of Lenalidomide in relapsed or refractory Hodgkin's lymphoma. The primary endpoint is objective response rate (CR + CRu + PR) as determined by International Workshop Criteria.
Initial treatment will consist of lenalidomide 25 mg PO daily given for 21 consecutive days (days 1 - 21), with seven days off on a 28 day cycle.Patients with PR, CR or CRu, may continue on therapy for 2 cycles past best response.Patients with PD at any time or those with evidence of SD after cycle 4 of monotherapy will be eligible to receive treatment with dexamethasone 40 mg PO daily on days 1 - 4 and 15 - 18 of a 28 day cycle while continuing protocol treatment if they continue to meet the criteria of continuation on therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide (Revlimid®)Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed Hodgkin's lymphoma that is relapsed or refractory (repeat biopsy is not mandatory) and is no longer eligible for curative treatment
- </=3 prior chemotherapy regimens (in patients without a prior ASCT)
- Patients with disease progression after ASCT will be eligible if they have received </= 1 additional chemotherapy regimen post-ASCT
- ECOG Performance Status 0-2
- Adequate hematological function:
Key exclusion criteria (9 listed)
- Prior treatment with Lenalidomide or Thalidomide
- Use of any other experimental therapy within the 28 days prior to baseline assessment
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C
- Pregnant or Lactating women
- Other significant medical problems such as uncontrolled hypertension, uncontrolled psychiatric symptoms disorders, serious infections, active peptic ulcer disease, or any other medical conditions that might be aggravated by treatment
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 |
|---|---|---|
| Lenalidomide (Revlimid®)Also: Revlimid25mg PO daily for 21 out of 28days per cycle | Drug | Lenalidomide |
Primary outcome
To assess the response rate (CR + CRu + PR) of Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma
Time frame: CT scans performed every two months while on therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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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.
John Kuruvilla principal investigator
Princess Margaret Hospital, Canada
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide (Revlimid®) in people with Hodgkin Disease, run by University Health Network, Toronto.
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 9 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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the response rate (CR + CRu + PR) of Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma (time frame: CT scans performed every two months while on therapy). 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 18 Sep 2020.