Hodgkin DiseasePhase 1NCT01207921

Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma

A Phase 1 study testing Lenalidomide in people with Hodgkin Disease, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 3 sitesUnited States
Study dates: 28 Apr 2011to 5 Mar 2021
Phase: Phase 1
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

Patient must have histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy.
Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. If the original diagnostic specimen is not available, relapsed or refractory specimens may be used. Bone marrow biopsies as the sole means of diagnosis are not acceptable; however, they may be used in conjunction with nodal biopsies. Fine needle aspirates (FNA) are not acceptable. Pathology reports must be submitted with the appropriate CRFs, and the actual biopsy specimens are not requested for central review. Patients with cHL have one of the following WHO subtypes:
Nodular sclerosis Hodgkin lymphoma
Lymphocyte-rich Hodgkin lymphoma
Mixed cellularity Hodgkin lymphoma
Lymphocyte-deplete Hodgkin lymphoma cHL patients without one of these subtypes designated cHL not otherwise specified are also eligible.

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NOTE: Patients with nodular lymphocyte-predominant HL are not eligible.
Patient must have undergone autologous stem cell transplant (ASCT) between 60 and 90 days prior to study registration.
Patient must be ≥ 18 years old.
Patient must have an ECOG performance status of ≤ 2 at study entry.
Patient must have adequate hematologic, renal, and hepatic function as defined by:
Absolute neutrophil count ≥ 1000 / μL
Platelets ≥ 30,000 / μL
Serum creatinine ≤ 1.5 X institution upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL
AST (SGOT) and ALT (SGPT) ≤ 3 x ULN (if not attributed to cHL)
Patient must be disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Patient must understand and voluntarily sign an informed consent form.
Patient must be able to adhere to the study visit schedule and other protocol requirements.
If a female of childbearing potential (FCBP), patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed
A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
A FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing the study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
If male, patient must agree to use a latex condom during sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.

Who cannot join

Patient who has undergone allogeneic stem cell transplantation.
Patient who shows evidence of progressive disease during salvage chemotherapy or following ASCT.
Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form.
Patient has any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Patient has used any other anti-cancer drug or therapy, including experimental, within 30 days of initiation of lenalidomide treatment (radiation therapy is allowed within 30 days).
Patient has known hypersensitivity to thalidomide.

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Patient developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Patient has any prior use of lenalidomide.
Patient is known to be positive for HIV or infectious hepatitis, type A, B, or C.
Patient is pregnant or breastfeeding.
Patient has concurrent use of other anti-cancer agents or treatments.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Ohio State University
Columbus, Ohio, 43210
Washington University School of Medicine
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27106

Other trials in United States

About this study

Official title: A Pilot Study of Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Hodgkin Lymphoma

The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant

Read the detailed description

Primary Objectives

-To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous stem cell transplant, as measured by dropout rate.

Secondary Objectives

To assess overall survival, event free survival, and progression free survival.
To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
To assess the conversion of partial response/stable disease post-ASCT to complete response.
To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).

Conditions: Hodgkin Disease
Being tested: Lenalidomide
Medical subject headings: Hodgkin Disease

What participants receive

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

LenalidomideDrug
Also called Revlimid

Study groups in NCT01207921
Study group	Role	What they receive
Arm 1	Experimental	Lenalidomide 15 mg/day Cycle 1 (28 days). If no unacceptable side effects Cycle 2 (28 days) will be lenalidomide 20 mg/day. If no unacceptable side effects Cycles 3 thru 18 (28 days for each cycle) will be lenalidomide 25 mg/day. Receives: Drug: Lenalidomide

What is being measured

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

To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate.
Will be described by the proportion of patients who drop out of the study for drug-related reasons at or before 12 months
Measured: 12 months

Secondary outcomes (6)

Overall survival (OS)
Measured: Until death (estimated to be 10 years)
Adverse event profile
To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
Measured: From start of treatment through 30 days following completion of treatment
Conversion of partial response/stable disease post-ASCT to complete response.
To assess the conversion of partial response/stable disease post-autologous stem cell transplant to complete response.
Measured: 1 year
Evaluate immune response
To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).
Measured: Through 30 days after end of treatment
Event-free survival (EFS)
Measured: Until progression or death (whichever comes first) - estimated to be 10 years
Progression-free survival (PFS)
Measured: Until progression (estimated to be 10 years)

Timeline

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

28 Apr 20115 Mar 2021

First posted23 Sep 2010 (estimated)
Study start28 Apr 2011
Primary completion19 Sep 2016
Study completion5 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01207921
Sponsor's protocol ID: 201010719
Status last verified: Mar 2021
First submitted: 21 Sep 2010
Last updated: 10 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bartlett NL. Modern treatment of Hodgkin lymphoma. Curr Opin Hematol. 2008 Jul;15(4):408-14. doi: 10.1097/MOH.0b013e328302c9d8.
PubMed 18536581
Fehniger, T.A., et al., A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma. ASH Annual Meeting Abstracts, 2009. 114(22): p. 3693-.
Boll B, Borchmann P, Topp MS, Hanel M, Reiners KS, Engert A, Naumann R. Lenalidomide in patients with refractory or multiple relapsed Hodgkin lymphoma. Br J Haematol. 2010 Feb;148(3):480-2. doi: 10.1111/j.1365-2141.2009.07963.x. Epub 2009 Oct 15. No abstract available.
PubMed 19863533
Attal, M., et al., Lenalidomide After Autologous Transplantation for Myeloma: First Analysis of a Prospective, Randomized Study of the Intergroupe Francophone Du Myelome (IFM 2005 02). ASH Annual Meeting Abstracts, 2009. 114(22): p. 529-.
Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
PubMed 17242396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT01207921
Acronym / sponsor ID: 201010719
Conditions: Hodgkin Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Celgene Corporation
Study start: 28 Apr 2011 (actual)
Primary completion: 19 Sep 2016 (actual)
Study completion: 5 Mar 2021 (actual)
First posted: 23 Sep 2010 (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 to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant

Detailed description

Primary Objectives

-To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous stem cell transplant, as measured by dropout rate.

Secondary Objectives

To assess overall survival, event free survival, and progression free survival.
To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
To assess the conversion of partial response/stable disease post-ASCT to complete response.
To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1	Experimental	Drug: LenalidomideLenalidomide 15 mg/day Cycle 1 (28 days). If no unacceptable side effects Cycle 2 (28 days) will be lenalidomide 20 mg/day. If no unacceptable side effects Cycles 3 thru 18 (28 days for each cycle) will be lenalidomide 25 mg/day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

Patient must have histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy.
Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. If the original diagnostic specimen is not available, relapsed or refractory specimens may be used. Bone marrow biopsies as the sole means of diagnosis are not acceptable; however, they may be used in conjunction with nodal biopsies. Fine needle aspirates (FNA) are not acceptable. Pathology reports must be submitted with the appropriate CRFs, and the actual biopsy specimens are not requested for central review. Patients with cHL have one of the following WHO subtypes:
NOTE: Patients with nodular lymphocyte-predominant HL are not eligible.
Patient must have undergone autologous stem cell transplant (ASCT) between 60 and 90 days prior to study registration.
Patient must be ≥ 18 years old.

Key exclusion criteria (11 listed)

Patient who has undergone allogeneic stem cell transplantation.
Patient who shows evidence of progressive disease during salvage chemotherapy or following ASCT.
Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form.
Patient has any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Patient has used any other anti-cancer drug or therapy, including experimental, within 30 days of initiation of lenalidomide treatment (radiation therapy is allowed within 30 days).

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
LenalidomideAlso: Revlimid	Drug	Arm 1

Primary outcome

To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate.
Time frame: 12 months
Will be described by the proportion of patients who drop out of the study for drug-related reasons at or before 12 months

6 secondary outcomes

Overall survival (OS)
Time frame: Until death (estimated to be 10 years)
Adverse event profile
Time frame: From start of treatment through 30 days following completion of treatment
Conversion of partial response/stable disease post-ASCT to complete response.
Time frame: 1 year
Evaluate immune response
Time frame: Through 30 days after end of treatment
Event-free survival (EFS)
Time frame: Until progression or death (whichever comes first) - estimated to be 10 years
Progression-free survival (PFS)
Time frame: Until progression (estimated to be 10 years)

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 10 Mar 2021.
Background: PubMed 18536581Bartlett NL. Modern treatment of Hodgkin lymphoma. Curr Opin Hematol. 2008 Jul;15(4):408-14. doi: 10.1097/MOH.0b013e328302c9d8.
BackgroundFehniger, T.A., et al., A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma. ASH Annual Meeting Abstracts, 2009. 114(22): p. 3693-.
Background: PubMed 19863533Boll B, Borchmann P, Topp MS, Hanel M, Reiners KS, Engert A, Naumann R. Lenalidomide in patients with refractory or multiple relapsed Hodgkin lymphoma. Br J Haematol. 2010 Feb;148(3):480-2. doi: 10.1111/j.1365-2141.2009.07963.x. Epub 2009 Oct 15. No abstract available.
BackgroundAttal, M., et al., Lenalidomide After Autologous Transplantation for Myeloma: First Analysis of a Prospective, Randomized Study of the Intergroupe Francophone Du Myelome (IFM 2005 02). ASH Annual Meeting Abstracts, 2009. 114(22): p. 529-.
Background: PubMed 17242396Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Cutaneous T-cell Lymphoma, Sezary Syndrome
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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.

Todd Fehniger, M.D., Ph.D. principal investigator

Washington University School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide in people with Hodgkin Disease, run by Washington University School of Medicine at 3 sites in United States.

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 25 inclusion and 11 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 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.

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 evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate. (time frame: 12 months). 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 NCT01207921, which also lists 5 linked publications.

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 10 Mar 2021.