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Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High- risk Relapsed or Refractory CLLA prospective multi-centre phase II study


- candidate number4125
- NTR NumberNTR1461
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-sep-2008
- Secondary IDsHO88 EudraCT number 2007-005487-28
- Public TitleAllogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High- risk Relapsed or Refractory CLLA prospective multi-centre phase II study
- Scientific TitleAllogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High- risk Relapsed or Refractory CLLA prospective multi-centre phase II study
- ACRONYMHOVON 88 CLL
- hypothesisThe hypothesis to be tested is that reinduction treatment with at least three courses of R-DHAP followed by RIC AlloSCT is feasible and efficacy meets the expectations as described in the protocol.
- Healt Condition(s) or Problem(s) studiedChronic Lymfocytic Leukemia (CLL), Stem cell transplantation , Allogeneic stem cell transplantation
- Inclusion criteria1. B-CLL confirmed according to WHO Classification;
2. Fludarabine refractory, defined as no response or relapse within 12 months after the last administration of fludarabine monotherapy or fludarabine containing regimen, and needing treatment, or Refractory or relapsed and needing treatment and having deletion of 17p13 or Refractory or relapsed within 24 months after the last administration of fludarabine combined with a monoclonal antibody and needing treatment;
3. Age 18-70 years inclusive;
4. WHO performance status 2;
5. HCT-CI 2;
6. Written informed consent.
- Exclusion criteria1. Intolerance to exogenous protein administration;
2. Previously treated with DHAP;
3. Richter.s transformation;
4. Suspected or documented CNS involvement by CLL;
5. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
6. Severe pulmonary dysfunction (CTCAE grade III-IV;
7. Severe neurological or psychiatric disease;
8. Significant hepatic dysfunction (serum bilirubin or transaminases 3 times upper limit of normal) except when caused by leukemic infiltration;
9. Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
10. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
11. Active, uncontrolled infections;
12. Patient known to be HIV-positive;
13. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
14. Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2008
- planned closingdate1-okt-2015
- Target number of participants50
- InterventionsAll patients will be treated with at least three courses of R-DHAP (rituximab, dexamethasone, cisplatin, cytarabin, 4 days every 4 weeks) while a HLA-identical donor is being searched. Patients with a donor and responsive or stable disease (SD) after at least three courses R-DHAP proceed to RIC alloSCT. DLI will be given for increasing minimal residual disease (MRD) after cessation of immunosuppression. In case no suitable donor is found, responsive patients are treated with additional courses of R-DHAP until a total of 6 courses from registration on have been administered.
- Primary outcomeProgression-free survival from registration with progression defined as time to:a. death due to any cause, orb. progression or relapse excluding progressive MRD triggering cessation of immunosuppression or DLI whichever comes first
- Secondary outcome- incidence and severity of tumor lysis during first course of R-DHAP;
- response to three courses of R-DHAP including SD;
- percentage of successful donor searches;
- percentage of patients who received alloSCT;
- best response on protocol;
- engraftment after alloSCT;
- incidence and severity of acute and chronic GVHD;
- toxicity;
- overall survival (OS) from registration;
- response of MRD to immunomodulation (either accelerated cessation of immunosuppression or DLI);
- response of PD to recommended off-protocol immunomodulation (either accelerated cessation of immunosuppression or DLI);
- disease status at two years after registration;
- PFS and OS after alloSCT.
- TimepointsAt entry, after 3 courses of R-DHAP, at 3 months after SCT and thereafter at 3 or 2 months intervals until 24 months, dependingon disease status. In case no donor was found: after the last R-DHAP and then at 3, 6, 9, 12 and 24 months or until progression.
- Trial web sitehttp://www.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Gelder, van
- CONTACT for SCIENTIFIC QUERIESDr. M. Gelder, van
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Johnson&Johnson-Orthobiotech, Novartis
- PublicationsN/A
- Brief summaryStudy phase: Phase II.

Study objective:
Evaluation of the effect of salvage therapywith R-DHAP followed by reduced-intensity conditioning and allogeneic stem cell transplantation from a sibling or unrelated donor.

Patient population:
Patients with B-CLL, in need of treatment and either refractory to fludarabine, or relapsed within one year after last fludarabine gift or within two years after fludarabine combined with monoclonal antibody or refractory /relapsed and having 17p deletion and age 18-70 years and hematopoeitic stem cell transplantation comorbidity index 2.

Study design:
Prospective, multicenter, non-randomized.

Duration of treatment:
Duration of salvage therapy at least three months, depending on donor availability; duration of stem cell transplantation and subsequent period in which immunomodulation may be applied (earlier cessation of immunosuppression or DLI) maximum two years from registration.
- Main changes (audit trail)
- RECORD26-sep-2008 - 6-okt-2008


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