Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma

NCT01207921 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 201010719
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hodgkin Disease

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (6)

• Overall survival (OS)

  Until death (estimated to be 10 years)

• Adverse event profile

  From start of treatment through 30 days following completion of treatment

• Conversion of partial response/stable disease post-ASCT to complete response.

  1 year

• Evaluate immune response

  Through 30 days after end of treatment

• Event-free survival (EFS)

  Until progression or death (whichever comes first) - estimated to be 10 years

Study Arms (1)

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.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: Revlimid

Arm 1

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celgene Corporation: collaborator

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• Bartlett NL. Modern treatment of Hodgkin lymphoma. Curr Opin Hematol. 2008 Jul;15(4):408-14. doi: 10.1097/MOH.0b013e328302c9d8.

  PMID: 18536581 BACKGROUND

• 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-.

  BACKGROUND

• 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.

  PMID: 19863533 BACKGROUND

• 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-.

  BACKGROUND

• 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.

  PMID: 17242396 BACKGROUND

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Todd Fehniger, M.D., Ph.D.

  Washington University School of Medicine

  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: September 21, 2010
• First Posted: September 23, 2010
• Study Start: April 28, 2011
• Primary Completion: September 19, 2016
• Study Completion: March 5, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)