Trial · NCT01976182
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 | Complete response (CR) | at Month 4 | The main endpoint will be the hematological CR rate evaluated after 4 months of treatment (binary endpoint). Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin \>12g/dL, platelets \>150x109/L, ANC \>1.5x109/L), lymphocytosis \<4x109/L and circulating LGL in the normal range (\<0.3x109/L). The number of LGL will be quantitated on blood smears. |
| Secondary | overall response rate (ORR) | at Month 4, and at Month 8 and Month 12 in non-responders at Month 4 | Hematological overall response rate (ORR) defined as the sum of complete responses and partial responses over the total number of patients. |
| Secondary | Complete response (CR) | at Month 8 and Month 12 | Complete response (CR) is defined as a normalization of clinical examination (disappearance of splenomegaly) and a complete normalization of blood counts (i.e., hemoglobin \>12g/dL, platelets \>150x109/L, ANC \>1.5x109/L), lymphocytosis \<4x109/L and circulating LGL in the normal range (\<0.3x109/L). The number of LGL will be quantitated on blood smears. |
| Secondary | Hematological partial response (PR) | at Month 4, Month 8 and Month 12 | Hematological partial response (PR) defined as an improvement in blood counts which do not meet criteria for complete remission (e.g., ANC increasing more than 50% and reaching more than 0.5 but less than 1.5x109/L with non-recurrence of infections, or hemoglobin level increasing more than 2 g/dL from baseline and transfusion requirements stopping without normalization of the hemoglobin level defined as hemoglobin \>12g/dL). |
| Secondary | Progressive disease | at Month 4, Month 8 and Month 12 | Progressive disease defined as worsening of cytopenia or organomegaly or incidence of infections. |
| Secondary | Time-to-relapse | from Month 4 to endpoint (in first-line treatment responders) | Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC \<1x109/L and/or hemoglobin \<10g/dL) or clonal LGL \>0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests. |
| Secondary | Time-to-relapse | from Month 8 to endpoint (in second-line treatment responders) | Time-to-relapse (censored variable). Relapse is defined as re-occurrence of either neutropenia or anemia (ANC \<1x109/L and/or hemoglobin \<10g/dL) or clonal LGL \>0.5x109/L in complete responders, or as a return to baseline values of either ANC or hemoglobin in partial responders, at two monthly consecutive blood tests. |
| Secondary | Molecular remission | at Month 4 and Month 12 for hematological complete responders | Molecular remission defined as the disappearance of the clonal pattern of TCR gamma multiplex rearrangement and Phenotypic remission is defined as : * For the T subtype: disappearance of the excess of CD3+/CD8+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion); * For the NK subtype: disappearance of the excess of CD3-/CD56+ cells (or disappearance of the LGL clone according to the specific subtype observed at inclusion) |
| Secondary | Adverse events rate | Month 2, Month 4, Month 6, Month 8, Month 10, Month 12 | Adverse events rate |
| Secondary | Compliance | Month 2, Month 4, Month 6, Month 8, Month 10, Month 12 | Compliance |
| Secondary | relationship between the response to treatment and the phenotypic subtype | Day 1 | Identification of a relationship between the response to treatment and the phenotypic subtype characterized by the panel of monoclonal antibodies defined in the ancillary study subsection. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01976182/registered