Clinical trial · Interventional

Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia

Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)

NCT00445900CI-TRIAL-00004579completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia. PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Secondary Myelofibrosis	—	UNRESOLVED	—

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
biopsy	Procedure	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
immunohistochemistry staining method	Other	—	UNRESOLVED
laboratory biomarker analysis	Other	—	UNRESOLVED
prednisone	Drug	Prednisone	ALIAS
thalidomide	Drug	Thalidomide	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)

Secondary outcomes (6)

measure
Constitutional symptom status and bone marrow morphology
measure
Overall survival
measure
Progression-free survival
measure
Time to progression
measure
Duration of response
measure
Toxicity as measured by NCI CTC v 2.0

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes:

  * Agnogenic myeloid metaplasia
  * Post-polycythemic myeloid metaplasia
  * Post-thrombocythemic myeloid metaplasia
* Must have 1 of the following MMM-related conditions:

  * Anemia, defined as hemoglobin \< 10 g/dL

    * Iron deficiency must be excluded as cause
  * Thrombocytopenia, defined as platelet count \< 100,000/mm³
  * Palpable hepatomegaly or splenomegaly
* No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following:

  * Metastatic carcinoma
  * Lymphoma
  * Myelodysplasia
  * Hairy cell leukemia
  * Mast cell disease
  * Acute leukemia (including M7 type)
  * Acute myelofibrosis
* No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Absolute neutrophil count ≥ 750/mm³
* Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM
* AST ≤ 5 times ULN, unless elevation due to MMM
* Creatinine ≤ 2.5 mg/dL
* No uncontrolled infection, including tuberculosis

  * No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy

    * Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed
* No federal medical center inmates or other incarcerated patients
* No peripheral neuropathy ≥ grade 2
* No comorbid condition in which the use of study therapy is felt to be potentially harmful
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception

PRIOR CONCURRENT THERAPY:

* No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days
* Prior splenectomy for MMM allowed
* No concurrent hematopoietic growth factors

References

Publications (0)

Data not yet available

No reference posted for this study.