Unrecognized Condition: Mature B or T-cell NeoplasmPhase 2NCT02701517

Cyclosporine Plus Methotrexate or Alemtuzumab

A Phase 2 study testing Cyclosporine + METHOTREXATE and Cyclosporine + CAMPATH-1H in people with Unrecognized Condition: Mature B or T-cell Neoplasm, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 65 years
Conditions the study is for: Unrecognized Condition: Mature B or T-cell Neoplasm
What is being tested?: Cyclosporine + METHOTREXATE and Cyclosporine + CAMPATH-1H
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 5 sitesin 2 countries
Study dates: Sep 2003to Nov 2009
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Having an identical Human Leukocyte Antigens (HLA) or a mismatched family donor.
Age between 45 and 65 years (outside this age range at the discretion of each center).
Indications:
Follicular lymphoma with one of the following characteristics:
Poor prognosis follicular NHL (3 or more factors by Federico et al: erythrocyte sedimentation rate (ESR)> 30, male,> 60 years, high LDH> 2 extranodal areas, pathologic stage (PS) >2 or The International Prognostic Index (IPI) 3 or high lactate dehydrogenase (LDH) or micro Beta 2) failing to achieve CR with regimens including fludarabine and anti CD20 (cluster of differentiation antigen 20 ).
2nd CR (complete response) or PR (partial response) not candidates for autologous transplantation;

Show all 25Show fewer

persistent disease or relapse after autologous transplantation.
Other low-grade lymphomas:
relapsed after autologous transplantation.
autologous transplant candidates which can not be performed because of the inability to collect a sufficient number of cells, steam cells disease persistence, etc..
Chronic lymphocytic leukemia with one of the following characteristics:
"B" symptoms: weight loss >10% in the last 6 months, fever >38ºC (degrees centigrade) for 14 days without infection, night sweats without infection
lymphadenopathy >10 cm or progressive, progressive splenomegaly
Anemia and/or thrombocytopenia secondary to bone marrow infiltration
Diffuse lymphocytic infiltration of the bone marrow
Progressive lymphocytosis (>50% in 2 months) or a lymphocyte doubling time <12 months Any of the above criteria is an inclusion criteria in the protocol in patients who have received at least one line of treatment including fludarabine
Patients with poor prognostic cytogenetic abnormalities: 17p-, 11q-with VDJ unmutated
Patients must also meet the following general requirements:
Performance status <3 (Zubrod score, Eastern Cooperative Oncology Group (ECOG) performance status or WHO (World Health Organization) )
forced expiratory volume at one second (FEV1) > 39%, lung diffusing capacity for carbon monoxide (DLCO) and forced vital capacity (FVC) > 39% of the theoretical values
Total bilirubin and transaminases <3 x the normal maximum value, unless attributable to base haemopathy
Creatinine <2 x normal maximum and clearance> 40 mL / min unless attributable to his base haemopathy
No evidence of symptomatic disease, cirrhosis or active hepatitis
Negative serology for HIV
Written informed consent

Who cannot join

Impaired hepatic or renal function superior to that described above
Presence of serious diseases that prevent chemotherapy treatments
Presence of psychiatric comorbidity
HIV infection
Other prior neoplasm
Do not have signed informed consent
Pregnant or at risk of pregnancy by inadequate contraceptive measures.
Patients diagnosed with chronic lymphocytic leukemia (CLL) transformation to more aggressive cytologic or histologic forms (prolymphocytic leukemia, large cell lymphoma, Hodgkin's disease) and those affected with autoimmune hemolytic anemia

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Spain4 sites

Clinical Hematology Department. ICO-Hospital Germans Trias i Pujol. Jose Carreras Research Institute
Badalona, Barcelona
Hospital Clinic I Provincial
Barcelona
Santa Creu I Sant Pau Hospital
Barcelona
Hospital Universitario de Salamanca
Salamanca

Other trials in Spain

Poland1 site

Department of Propedeutic Oncology, Medical University of Gdansk
Gdansk

Other trials in Poland

About this study

Official title: Randomized Trial of Cyclosporine + CAMPATH-1H (ALEMTUZUMAB) vs. Cyclosporine + METHOTREXATE in Patients Diagnosed With Mature B-cell Neoplasms - Chronic Lymphocytic Leukemia and Low-grade Lymphomas - Receiving Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning Regimen

The primary aim of the study was to compare the efficacy of the procedure in terms of event-free survival between patients receiving cyclosporine (CsA) plus either alemtuzumab (CAMPATH-1H ) or methotrexate (MTX) after matched related donor allo-reduced intensity conditioning. Secondary aims were: 1. To compare the incidence of infections and transplant-related mortality between the two arms; 2. to compare the incidence of acute and chronic GVHD 3. to evaluate hematologic and immunologic reconstitution and evolution of chimerism and residual disease.

Patients were randomly assigned to received cyclosporine plus alemtuzumab or cyclosporine plus MTX and were stratified according to diagnosis: Chronic lymphocytic leukemia or Low grade- non-Hodgkin's lymphoma.

All patients received the same reduced-intensity conditioning (RIC) scheme based on fludarabine 150mg/m2 (30 mg/m2/day everyday from -8 to -4) plus melphalan 140mg/m2 (70 mg/m2/day everyday from -3 to -2). Regarding the GVHD prophylaxis, patients in group 1 (n=17) received CsA 1 mg/kg intravenously starting on day -7 and 2/mg/Kg from day -1 plus alemtuzumab administered at a dose of 20 mg IV on -8 to -4 whereas in group 2 (n=23) pts received CsA at same doses as group 1 plus MTX given at a dose of 15 mg/m2 intravenously on days 1 and 10 mg/m2 on days 3, 6 and 11, followed by folinic acid rescue (15 mg in +1 and 10 mg in +3, +6 and +11 intravenously every 6 hours for 4 doses starting 24 hours after each dose of MTX).

Acute and chronic GVHD were similarly graded by established criteria [20, 21]. In patients receiving alemtuzumab, CsA was suspended by day +130. They also received donor lymphocyte infusion (DLI) at a dose of 1 x 107 cluster of differentiation 3 / kg on day +180 in case of active disease, persistence of minimal residual disease detected by flow cytometry or mixed chimerism and no GVHD. In case mixed chimerism, donor lymphocyte infusion was performed if patient hematopoiesis progressively increased. In patients receiving CsA + MTX, CsA was suspended by day +180. These patients received DLI only in situations specified above.

The statistical analysis has been designed to identify a 20% difference in terms of disease-free survival (based on the increased incidence of relapse in patients receiving T-cell depletion).

Conditions: Unrecognized Condition: Mature B or T-cell Neoplasm
Being tested: Cyclosporine + METHOTREXATE, Cyclosporine + CAMPATH-1H
Keywords: conditioning treatment, alemtuzumab, allogeneic hematopoietic stem cell transplantation, chronic lymphoproliferative disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cyclosporine + METHOTREXATEDrug
MTX days +1, +3, +6 and +11 followed by rescue with folinic Ac. All patients receive CSA from day -7.
Cyclosporine + CAMPATH-1HDrug
Also called Alemtuzumab
CAMPATH-1H at a dose of 20 mg / day at 8-hour intravenous infusion on days -8 to -4. All patients will receive CSA from day -7.

Study groups in NCT02701517
Study group	Role	What they receive
Cyclosporine + METHOTREXATE	Active comparator	MTX days +1, +3, +6 and +11 followed by folinic acid rescue. All patients will receive CSA from day -7. Receives: Drug: Cyclosporine + METHOTREXATE
Cyclosporine + CAMPATH-1H	Experimental	CAMPATH-1H at a dose of 20 mg / day at 8-hour intravenous infusion on days -8 to -4. All patients will receive CSA from day -7. Receives: Drug: Cyclosporine + CAMPATH-1H

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of transplantation in terms of event-free survival
To compare the efficacy of transplantation in terms of event-free survival between patients receiving CAMPATH-1H or methotrexate in allogeneic related donor with nonmyeloablative conditioning.
Measured: From +270 days

Secondary outcomes (1)

Incidence of infections and transplant-related mortality
Compare the incidence of infections and transplant-related mortality between the two arms
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Nov 2009

First posted8 Mar 2016 (estimated)
Study startSep 2003
Primary completionNov 2009
Study completionNov 2009

Why it stopped: The trial was stopped before the targeted number of patients was reached due to lack of support.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Unrecognized Condition: Mature B or T-cell NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02701517
Sponsor's protocol ID: TIRCAMPATH-alo 2002
Status last verified: Dec 2017
First submitted: 12 Mar 2015
Last updated: 29 Dec 2017
Results posted: No
Data monitoring committee: No

Publications

Kroger N, Shaw B, Iacobelli S, Zabelina T, Peggs K, Shimoni A, Nagler A, Binder T, Eiermann T, Madrigal A, Schwerdtfeger R, Kiehl M, Sayer HG, Beyer J, Bornhauser M, Ayuk F, Zander AR, Marks DI; Clinical Trial Committee of the British Society of Blood and Marrow Transplantation and the German Cooperative Transplant Group. Comparison between antithymocyte globulin and alemtuzumab and the possible impact of KIR-ligand mismatch after dose-reduced conditioning and unrelated stem cell transplantation in patients with multiple myeloma. Br J Haematol. 2005 Jun;129(5):631-43. doi: 10.1111/j.1365-2141.2005.05513.x.
PubMed 15916686
Chen PM, Tzeng CH, Fan FS, Hsieh RK, Wei CH. Bone marrow transplantation in Taiwan: low incidence of acute GVHD in patients with hematologic malignancies and severe aplastic anemia. Bone Marrow Transplant. 1994 Jun;13(6):709-11.
PubMed 7920299
Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
PubMed 7581076
Sullivan KM, Shulman HM, Storb R, Weiden PL, Witherspoon RP, McDonald GB, Schubert MM, Atkinson K, Thomas ED. Chronic graft-versus-host disease in 52 patients: adverse natural course and successful treatment with combination immunosuppression. Blood. 1981 Feb;57(2):267-76.
PubMed 7004534
Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. doi: 10.1182/blood-2004-03-1105. Epub 2004 Aug 10.
PubMed 15304395
Delgado J, Pillai S, Benjamin R, Caballero D, Martino R, Nathwani A, Lovell R, Thomson K, Perez-Simon JA, Sureda A, Kottaridis P, Vazquez L, Peggs K, Sierra J, Milligan D, Mackinnon S. The effect of in vivo T cell depletion with alemtuzumab on reduced-intensity allogeneic hematopoietic cell transplantation for chronic lymphocytic leukemia. Biol Blood Marrow Transplant. 2008 Nov;14(11):1288-97. doi: 10.1016/j.bbmt.2008.09.001.
PubMed 18940684
Perez-Simon JA, Kottaridis PD, Martino R, Craddock C, Caballero D, Chopra R, Garcia-Conde J, Milligan DW, Schey S, Urbano-Ispizua A, Parker A, Leon A, Yong K, Sureda A, Hunter A, Sierra J, Goldstone AH, Linch DC, San Miguel JF, Mackinnon S; Spanish and United Kingdom Collaborative Groups for Nonmyeloablative Transplantation. Nonmyeloablative transplantation with or without alemtuzumab: comparison between 2 prospective studies in patients with lymphoproliferative disorders. Blood. 2002 Nov 1;100(9):3121-7. doi: 10.1182/blood-2002-03-0701.
PubMed 12384408
Martino R, Caballero MD, Canals C, Simon JA, Solano C, Urbano-Ispizua A, Bargay J, Rayon C, Leon A, Sarra J, Odriozola J, Conde JG, Sierra J, San Miguel J; ALLOPBSCT Subcommittee of the Spanish Group for Haematopoietic Transplantation (GETH); Group GEL-TAMO. Allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning: results of a prospective multicentre study. Br J Haematol. 2001 Dec;115(3):653-9. doi: 10.1046/j.1365-2141.2001.03153.x.
PubMed 11736950
Schweighofer CD, Ritgen M, Eichhorst BF, Busch R, Abenhardt W, Kneba M, Hallek M, Wendtner CM. Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG). Br J Haematol. 2009 Jan;144(1):95-8. doi: 10.1111/j.1365-2141.2008.07394.x. Epub 2008 Oct 30.
PubMed 19016732
Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002 May 15;99(10):3554-61. doi: 10.1182/blood.v99.10.3554.
PubMed 11986207
Rai KR, Freter CE, Mercier RJ, Cooper MR, Mitchell BS, Stadtmauer EA, Santabarbara P, Wacker B, Brettman L. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002 Sep 15;20(18):3891-7. doi: 10.1200/JCO.2002.06.119.
PubMed 12228210
Osterborg A, Dyer MJ, Bunjes D, Pangalis GA, Bastion Y, Catovsky D, Mellstedt H. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol. 1997 Apr;15(4):1567-74. doi: 10.1200/JCO.1997.15.4.1567.
PubMed 9193354
Chakrabarti S, Mackinnon S, Chopra R, Kottaridis PD, Peggs K, O'Gorman P, Chakraverty R, Marshall T, Osman H, Mahendra P, Craddock C, Waldmann H, Hale G, Fegan CD, Yong K, Goldstone AH, Linch DC, Milligan DW. High incidence of cytomegalovirus infection after nonmyeloablative stem cell transplantation: potential role of Campath-1H in delaying immune reconstitution. Blood. 2002 Jun 15;99(12):4357-63. doi: 10.1182/blood.v99.12.4357.
PubMed 12036862
Hale G, Cobbold S, Novitzky N, Bunjes D, Willemze R, Prentice HG, Milligan D, MacKinnon S, Waldmann H; CAMPATH Users. CAMPATH-1 antibodies in stem-cell transplantation. Cytotherapy. 2001;3(3):145-64. doi: 10.1080/146532401753173981.
PubMed 12171722
Kottaridis PD, Milligan DW, Chopra R, Chakraverty RK, Chakrabarti S, Robinson S, Peggs K, Verfuerth S, Pettengell R, Marsh JC, Schey S, Mahendra P, Morgan GJ, Hale G, Waldmann H, de Elvira MC, Williams CD, Devereux S, Linch DC, Goldstone AH, Mackinnon S. In vivo CAMPATH-1H prevents graft-versus-host disease following nonmyeloablative stem cell transplantation. Blood. 2000 Oct 1;96(7):2419-25.
PubMed 11001893

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Cyclosporine + CAMPATH-1H (ALEMTUZUMAB) vs. Cyclosporine + METHOTREXATE in Patients Diagnosed With Mature B-cell Neoplasms - Chronic Lymphocytic Leukemia and Low-grade Lymphomas - Receiving Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning Regimen
ClinicalTrials.gov ID: NCT02701517
Acronym / sponsor ID: TIRCAMPATH-alo 2002
Conditions: Unrecognized Condition: Mature B or T-cell Neoplasm
Keywords: conditioning treatment, alemtuzumab, allogeneic hematopoietic stem cell transplantation, chronic lymphoproliferative disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was stopped before the targeted number of patients was reached due to lack of support.
Enrolment: 72 participants (estimated)
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
Study start: Sep 2003
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 8 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The statistical analysis has been designed to identify a 20% difference in terms of disease-free survival (based on the increased incidence of relapse in patients receiving T-cell depletion).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cyclosporine + METHOTREXATE	Active comparator	Drug: Cyclosporine + METHOTREXATEMTX days +1, +3, +6 and +11 followed by folinic acid rescue. All patients will receive CSA from day -7.
Cyclosporine + CAMPATH-1H	Experimental	Drug: Cyclosporine + CAMPATH-1HCAMPATH-1H at a dose of 20 mg / day at 8-hour intravenous infusion on days -8 to -4. All patients will receive CSA from day -7.

Who may qualify

Ages: 45 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

Having an identical Human Leukocyte Antigens (HLA) or a mismatched family donor.
Age between 45 and 65 years (outside this age range at the discretion of each center).
Indications:
Patients must also meet the following general requirements:

Key exclusion criteria (8 listed)

Impaired hepatic or renal function superior to that described above
Presence of serious diseases that prevent chemotherapy treatments
Presence of psychiatric comorbidity
HIV infection
Other prior neoplasm

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cyclosporine + METHOTREXATEMTX days +1, +3, +6 and +11 followed by rescue with folinic Ac. All patients receive CSA from day -7.	Drug	Cyclosporine + METHOTREXATE
Cyclosporine + CAMPATH-1HAlso: AlemtuzumabCAMPATH-1H at a dose of 20 mg / day at 8-hour intravenous infusion on days -8 to -4. All patients will receive CSA from day -7.	Drug	Cyclosporine + CAMPATH-1H

Primary outcome

Efficacy of transplantation in terms of event-free survival
Time frame: From +270 days
To compare the efficacy of transplantation in terms of event-free survival between patients receiving CAMPATH-1H or methotrexate in allogeneic related donor with nonmyeloablative conditioning.

1 secondary outcome

Incidence of infections and transplant-related mortality
Time frame: 1 year

Results and safety

The study was stopped early (reason given: The trial was stopped before the targeted number of patients was reached due to lack of support.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Background: PubMed 15916686Kroger N, Shaw B, Iacobelli S, Zabelina T, Peggs K, Shimoni A, Nagler A, Binder T, Eiermann T, Madrigal A, Schwerdtfeger R, Kiehl M, Sayer HG, Beyer J, Bornhauser M, Ayuk F, Zander AR, Marks DI; Clinical Trial Committee of the British Society of Blood and Marrow Transplantation and the German Cooperative Transplant Group. Comparison between antithymocyte globulin and alemtuzumab and the possible impact of KIR-ligand mismatch after dose-reduced conditioning and unrelated stem cell transplantation in patients with multiple myeloma. Br J Haematol. 2005 Jun;129(5):631-43. doi: 10.1111/j.1365-2141.2005.05513.x.
Background: PubMed 7920299Chen PM, Tzeng CH, Fan FS, Hsieh RK, Wei CH. Bone marrow transplantation in Taiwan: low incidence of acute GVHD in patients with hematologic malignancies and severe aplastic anemia. Bone Marrow Transplant. 1994 Jun;13(6):709-11.
Background: PubMed 7581076Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
Background: PubMed 7004534Sullivan KM, Shulman HM, Storb R, Weiden PL, Witherspoon RP, McDonald GB, Schubert MM, Atkinson K, Thomas ED. Chronic graft-versus-host disease in 52 patients: adverse natural course and successful treatment with combination immunosuppression. Blood. 1981 Feb;57(2):267-76.
Background: PubMed 15304395Morris E, Thomson K, Craddock C, Mahendra P, Milligan D, Cook G, Smith GM, Parker A, Schey S, Chopra R, Hatton C, Tighe J, Hunter A, Peggs K, Linch D, Goldstone A, Mackinnon S. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood. 2004 Dec 15;104(13):3865-71. doi: 10.1182/blood-2004-03-1105. Epub 2004 Aug 10.
Background: PubMed 18940684Delgado J, Pillai S, Benjamin R, Caballero D, Martino R, Nathwani A, Lovell R, Thomson K, Perez-Simon JA, Sureda A, Kottaridis P, Vazquez L, Peggs K, Sierra J, Milligan D, Mackinnon S. The effect of in vivo T cell depletion with alemtuzumab on reduced-intensity allogeneic hematopoietic cell transplantation for chronic lymphocytic leukemia. Biol Blood Marrow Transplant. 2008 Nov;14(11):1288-97. doi: 10.1016/j.bbmt.2008.09.001.
Background: PubMed 12384408Perez-Simon JA, Kottaridis PD, Martino R, Craddock C, Caballero D, Chopra R, Garcia-Conde J, Milligan DW, Schey S, Urbano-Ispizua A, Parker A, Leon A, Yong K, Sureda A, Hunter A, Sierra J, Goldstone AH, Linch DC, San Miguel JF, Mackinnon S; Spanish and United Kingdom Collaborative Groups for Nonmyeloablative Transplantation. Nonmyeloablative transplantation with or without alemtuzumab: comparison between 2 prospective studies in patients with lymphoproliferative disorders. Blood. 2002 Nov 1;100(9):3121-7. doi: 10.1182/blood-2002-03-0701.
Background: PubMed 11736950Martino R, Caballero MD, Canals C, Simon JA, Solano C, Urbano-Ispizua A, Bargay J, Rayon C, Leon A, Sarra J, Odriozola J, Conde JG, Sierra J, San Miguel J; ALLOPBSCT Subcommittee of the Spanish Group for Haematopoietic Transplantation (GETH); Group GEL-TAMO. Allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning: results of a prospective multicentre study. Br J Haematol. 2001 Dec;115(3):653-9. doi: 10.1046/j.1365-2141.2001.03153.x.
Background: PubMed 19016732Schweighofer CD, Ritgen M, Eichhorst BF, Busch R, Abenhardt W, Kneba M, Hallek M, Wendtner CM. Consolidation with alemtuzumab improves progression-free survival in patients with chronic lymphocytic leukaemia (CLL) in first remission: long-term follow-up of a randomized phase III trial of the German CLL Study Group (GCLLSG). Br J Haematol. 2009 Jan;144(1):95-8. doi: 10.1111/j.1365-2141.2008.07394.x. Epub 2008 Oct 30.
Background: PubMed 11986207Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002 May 15;99(10):3554-61. doi: 10.1182/blood.v99.10.3554.
Background: PubMed 12228210Rai KR, Freter CE, Mercier RJ, Cooper MR, Mitchell BS, Stadtmauer EA, Santabarbara P, Wacker B, Brettman L. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002 Sep 15;20(18):3891-7. doi: 10.1200/JCO.2002.06.119.
Background: PubMed 9193354Osterborg A, Dyer MJ, Bunjes D, Pangalis GA, Bastion Y, Catovsky D, Mellstedt H. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol. 1997 Apr;15(4):1567-74. doi: 10.1200/JCO.1997.15.4.1567.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

José Antonio Pérez-Simón, MD, PhD principal investigator

University of Salamanca

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The trial was stopped before the targeted number of patients was reached due to lack of support.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of transplantation in terms of event-free survival (time frame: From +270 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02701517, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.