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Phase 2 N=48 Treatment

Lenalidomide and Prednisone in Treating Patients With Myelofibrosis

Essential Thrombocythemia · Polycythemia Vera · Primary Myelofibrosis

Enrolled (actual)
48
Serious AEs
100.0%
Results posted
Sep 2013
Primary outcome: Primary: Overall Response Rate — 0.26 Proportion of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
lenalidomide (Drug); prednisone (Drug); laboratory biomarker analysis (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate
0.26

Summary

This phase II trial is studying how well giving lenalidomide together with prednisone works in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with prednisone may kill more cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Patient must be diagnosed with myelofibrosis with myeloid metaplasia (MMM); agnogenic myeloid metaplasia, post-polycythemic myeloid metaplasia, or post-thrombocythemic myeloid metaplasia are included
  • NOTE: Diagnosis must be confirmed by central pathology review; diagnostic samples must be submitted; patient may register and begin treatment based on the local pathology review. If the central review does not confirm patient's eligibility to participate in the trial, protocol treatment must be discontinued
  • Patient must have discontinued chemotherapy (hydroxyurea, alpha interferon, anagrelide, other myelosuppressive agents, thalidomide, or any other experimental therapy) as well as growth factors and systemic use of corticosteroids >= 28 days prior to starting study drug
  • All non-hematologic toxicity must be resolved to = = 1,000 uL
  • Platelet count >= 100,000 uL
  • Serum creatinine =< 2.0 mg/dL
  • Total bilirubin =< 2.0 mg/dL (if elevated; direct bilirubin =< 2.0 mg/dL)
  • AST (SGOT) =< 3 x ULN unless attributed to hepatic extramedullary hematopoiesis
  • Women must not be pregnant or breastfeeding because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenetic effects on the developing fetus and newborn are unknown; women of childbearing potential who are sexually active, must use 2 accepted methods of birth control at the same time for 4 weeks prior to lenalidomide treatment, during lenalidomide treatment, and up to 4 weeks after lenalidomide treatment is finished; sexually active males must use a latex condom for contraception during the study and up to 4 weeks after treatment with lenalidomide has ended
  • All females of childbearing potential must have a blood test 10-14 days prior to the start of lenalidomide treatment to rule out pregnancy; another blood test to rule out pregnancy must be done 24 hours prior to the start of treatment with lenalidomide
  • Patient must not have any condition, including the presence of laboratory abnormalities, which, based on the physician's opinion, places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Patient must not have any known hypersensitivity to thalidomide or lenalidomide
  • Patient must not have any known positive status for HIV or infectious hepatitis type A, B or C
  • Patient must not have any other active malignancy
  • NOTE: SWOG patients are strongly encouraged to be registered on SWOG-9007 ("Cytogenetic Studies in Leukemia Patients"); SWOG institutions registering patients to SWOG-9007 should follow the instructions for specimen submission
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00227591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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