Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma

Completed · Phase 1

Conditions studied: Hodgkin Disease

In brief

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

Key facts

Study ID: NCT01207921
Run by: Washington University School of Medicine
People needed: 28
Starts: 2011-04-28
Expected to finish: 2021-03-05
Last updated by the study team: 2021-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
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®.

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.

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States
Wake Forest University — Winston-Salem, North Carolina, United States
Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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