Trial · NCT01976182
Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
NCT01976182, Phase 2, Completed, Rennes University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia. Trials, record NCT01976182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976182
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia
- NCT number
- NCT01976182
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Rennes University Hospital
- Conditions
- Large Granular Lymphocytes Leukemia
- Interventions
- Methotrexate, Cyclophosphamide
- First posted
- 2013-11-05
- Last updated
- 2025-01-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01976182
GET https://conductscience.org/api/trials/v1/NCT01976182/registered