Trial · NCT00726232
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3 | For a confirmed response all criteria must have been sustained for at least 2 months. CR: * Hematocrit \< 45% in men and \< 42% in women * No phlebotomy for 1 month * No palpable splenomegaly * White blood cells \< 10 x 10\^9/L with normal differential and platelets \< 400 x 10\^9/L * No sustained leucopenia or thrombocytopenia (\>2 weeks) * No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: * Hematocrit \< 45% in men and \< 42% in women * 50% reduction in phlebotomy requirements from 6 months before treatment started * 50% reduction in palpable splenomegaly |
| Primary | Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3. | For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response: * Platelet count \< 400 x 10\^9/L * White blood cell count \< 10 x 10\^9/L with normal differential and Hematocrit ≤ upper limit of normal * Absence of sustained (\> 2 weeks) anemia or leucopenia based on institutional normal ranges * Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias) * Absence of palpable splenomegaly Partial Clinical Response: * Platelet count \< 400 x 10\^9/L * 50% reduction in palpable splenomegaly |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | Baseline and Week 12 (Cycle 4, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and Week 24 (Cycle 7, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and Week 36 (Cycle 10, Day 1) | The individual components of clinical response included: * Hematocrit (Hct) \< 45% without phlebotomy * Absence of palpable splenomegaly * 50% reduction in spleen size * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks | Baseline and 4 weeks (Cycle 2, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | Baseline and 24 weeks (Cycle 7, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | Baseline and 36 weeks (Cycle 10, Day 1) | The individual components of clinical response included: * Platelet count ≤ 400 x 10\^9/L * White blood cell (WBC) count ≤ 10 x 10\^9/L * 50% reduction in spleen size * Absence of palpable splenomegaly |
| Secondary | Change From Baseline to Week 4 in Polycythemia Vera Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats. |
| Secondary | Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms | Baseline and Week 4 (Cycle 2, Day 1) | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness. |
| Secondary | Change From Baseline to Week 4 in Health-related Quality of Life | Baseline and Week 4 (Cycle 2, Day 1) | Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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