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Chronic Myeloproliferative DisordersPhase 2NCT00445900

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

A Phase 2 study testing cyclophosphamide, prednisone and thalidomide in people with Chronic Myeloproliferative Disorders and Secondary Myelofibrosis, run by Mayo Clinic.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cyclophosphamide, prednisone and thalidomide
Type of treatment
Surgery or procedure
How many people
22 participants
Where
No sites listed yet
Study dates
Oct 2004to Oct 2006
Phase
Phase 2
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

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

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the benefit of thalidomide, prednisone, and cyclophosphamide in alleviating disease-associated anemia, thrombocytopenia, and/or splenomegaly in patients with myelofibrosis with myeloid metaplasia (MMM).
  • Determine the benefit of this regimen in palliating four hypercatabolic constitutional symptoms (i.e., weight loss, fatigue, drenching night sweats, and unexplained fevers) in these patients.
  • Determine the toxicity profile of this regimen in these patients.

Secondary

  • Determine the effect of this regimen on leukocyte count.
  • Determine the effect of this regimen on bone marrow histology, including microvessel density and reticulin fibrosis.
  • Determine the effect of this regimen on intramedullary and urinary markers of angiogenesis.
  • Determine the effect of this regimen on circulating myeloid progenitor cells by quantifying CD34+ cells.

OUTLINE: Patients receive oral thalidomide, oral prednisone, and oral cyclophosphamide (TPC) once daily on days 1-28. Treatment repeats every 28 days for 3 courses. After 3 courses (3 months) of treatment, patients who respond to TPC therapy may receive oral thalidomide alone once daily for up to 3 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate and biopsy prior to study entry, 6 months after starting therapy, and then every 6 months for up to 3 years. Samples are analyzed by microvessel density/angiogenesis studies (i.e., CD34 immunohistochemical and vascular endothelium-specific staining) to determine the effect of therapy on markers of bone marrow angiogenesis.

After completion of study therapy, patients are followed every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

Being tested
cyclophosphamide, prednisone, thalidomide, immunohistochemistry staining method, laboratory biomarker analysis
Keywords
primary myelofibrosis, essential thrombocythemia, polycythemia vera, secondary myelofibrosis
Medical subject headings
Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential, Polycythemia Vera

What participants receive

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

What is being measured

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

  1. 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)

  1. Constitutional symptom status and bone marrow morphology

  2. Overall survival

  3. Progression-free survival

  4. Time to progression

  5. Duration of response

  6. Toxicity as measured by NCI CTC v 2.0

Timeline

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

  1. First posted9 Mar 2007 (estimated)
  2. Study startOct 2004
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445900
Sponsor's protocol ID
CDR0000530973
Other IDs
P30CA015083, MC028A, 1360-03
Status last verified
Mar 2011
First submitted
7 Mar 2007
Last updated
17 Mar 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cyclophosphamide, prednisone and thalidomide in people with Chronic Myeloproliferative Disorders and Secondary Myelofibrosis, run by Mayo Clinic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly). 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 NCT00445900.

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 17 Mar 2011.

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