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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009880 |
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Date of registration:
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30/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase-II study on the value of post-transplant Cyclophosphamide after Thiotepa-based haplo-identical stem-cell transplantation for relapsed-refractory lymphoma
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Scientific title:
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Phase-II study on the value of post-transplant Cyclophosphamide after Thiotepa-based haplo-identical stem-cell transplantation for relapsed-refractory lymphoma
- CHARLY |
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Date of first enrolment:
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16/05/2017 |
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Target sample size:
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49 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00009880 |
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Study type:
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interventional |
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Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
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Phase:
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2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Sascha
Dietrich |
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Address:
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Im Neuenheimer Feld 410
69120
Heidelberg
Germany |
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Telephone:
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+ 49 6221 56 39894 |
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Email:
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sascha.dietrich@med.uni-heidelberg.de |
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Affiliation:
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Universitätsklinikum HeidelbergInnere Medizin V |
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Name:
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Sascha
Dietrich |
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Address:
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Im Neuenheimer Feld 410
69120
Heidelberg
Germany |
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Telephone:
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+ 49 6221 56 39894 |
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Email:
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sascha.dietrich@med.uni-heidelberg.de |
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Affiliation:
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Universitätsklinikum HeidelbergInnere Medizin V |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent obtained according to international guidelines and local laws;
2. Male or female patients aged 18-65 years;
3. Diagnosis of one the following NHL subtypes (PTCL, DLBCL, MCL, FL, transformed CLL)
4. Refractoriness or early relapse (<12 months) after at least two regimens and/or auto-HSCT failure;
5. Intent-to Thiotepa based myeloablative Haplo-HSCT because of unavailability of a fully matched SIB or MUD (10/10), within the time frame for successful HSCT as determined by disease activity;
6. Eligible to undergo myeloablative allogeneic stem cell transplantation as judged by the treating transplant physician. E.g. patients with controlled clinically insignificant infections are eligible, whereas patients with active uncontrolled infections are not eligible.
7. ECOG performance status of 0 - 1;
8. Ability to understand the nature of the trial and the trial related procedures and to comply with them.
Exclusion criteria: 1. Patients with known congestive heart failure NYHA Class III and IV
2. Known HIV infection, infectious hepatitis (type B or C) or any other uncontrolled severe infection, i.e. patients with positive HIV test or active hepatitis B should be excluded. Only patients positive for anti-HBs+ with or without anti-HBc+ are allowed to enter the study. Patients with hepatitis C (anti-HCV+) should be excluded;
3. Known hypersensitivity to cyclophosphamide;
4. Renally impaired patients with creatinine clearance < 30 ml/min (Cockcroft-Gault equation);
5. Simultaneous participation in other clinical trials;
6. Participation in a clinical trial within the last 14 days before the date of registration of this trial;
7. Known abuse of medication, drugs or alcohol;
8. Female patients who are pregnant or breast feeding;
9. Fertile patients refusing to use safe contraceptive methods during the study.
10. Patients with uninary outflow obstructions or clinical signs of cystitis are not eligible.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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C85.9
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Non-Hodgkin lymphoma, unspecified
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C85.9
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Intervention(s)
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Group 1: cyclophosphamide, 50 mg/kg (infusion), day +3 und +4 after haplo-identical allogeneic hematopoietic stem cell transplantation (haplo-HSCT)
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Primary Outcome(s)
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Rate of progression-free survival (PFS) at one year post haplo-HSCT
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Secondary Outcome(s)
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- PFS over time
- OS at 12 months post HSCT
- Non-relapse mortality (NRM) at 12 months post HSCT
- OS over time
- Clinical response (NCI criteria) measured at day 100 after haplo-HSCT
- Rate of acute GVHD
- Rate of cGVHD
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Secondary ID(s)
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2015-003920-30
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Source(s) of Monetary Support
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Riemser Pharma GmbH
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Ethics review
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Status: Approved
Approval date: 25/10/2016
Contact:
ethikkommission-I@med.uni-heidelberg.de
Ethikkommission der Medizinischen Fakultät Heidelberg
+49-6221-338220
ethikkommission-I@med.uni-heidelberg.de
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