Pilot Study of Unrelated Cord Blood Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens.

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Detailed Description

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Conditions

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Leukemia, Myeloid, Acute Myelodysplastic Syndromes Leukemia, Lymphoblastic, Acute Lymphoma, Non-Hodgkin Hodgkin Disease Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Myeloblative conditioning regimen

Group Type OTHER

Thiotepa

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Intravenous busulphan

Intervention Type DRUG

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Reduced intensity conditioning regimen - FluCyTBI

Group Type OTHER

Fludarabine

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Reduced intensity conditioning regimen - FluMel

Group Type OTHER

Fludarabine

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Interventions

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Thiotepa

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Intravenous busulphan

Intervention Type DRUG

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Melphalan

Intervention Type DRUG

Thymoglobulin

Intervention Type DRUG

Ciclosporin

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Other Intervention Names

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Busilvex

Eligibility Criteria

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Inclusion Criteria

In general this encompasses all haematological disorders where a volunteer unrelated donor transplant is clinically indicated.

1. Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic transplantation is considered as the best treatment option.

1. Acute myeloid leukaemia (AML) in first complete remission (CR1) with one of the following characteristics:

* High risk cytogenetic or molecular alterations (e.g. t(9;22), deletion 7/7q-, monosomy 5 or del(5q), 3q26 alterations, complex karyotype \[3 or more anomalies\], p53 alterations, 11q23 especially t(6;11) abnormalities, FLT-3 ITD)
* Leukocytes at diagnosis \> 50 x109/l (except in cases with good prognosis molecular rearrangements for which leukocytes should be \> 100 x 109/l)
2. Myelodysplastic syndromes

* International Prognosis Index (IPSS) above 1 (intermediate group 2 or high risk)
* IPSS 0 or 0.5 in the presence of cytopenias requiring treatment.
3. Therapy related AML or MDS in first CR
4. AML or MDS in second (CR2) or subsequent CR
5. Ph'-positive chronic myeloid leukaemia

i. In first chronic phase if refractory and/or intolerance to tyrosine kinase inhibitors is clearly demonstrated ii. In second chronic phase
2. Acute lymphoblastic leukaemia (ALL)

a. In CR1 with one of the following characteristics: i. Very high risk chromosome or molecular alterations (e.g. t(9;22), t(4;11), complex karyotype in adults, bcr/abl rearrangements, MLL rearrangements) ii. Slow response to induction treatment defined as the presence of \>10% blasts in bone marrow at day 14 of induction treatment iii. Adults aged \> 30 years iv. Adults with B ALL cell line with a number of leukocytes at diagnosis \>25 x 109/L or T ALL cell line with a number of leukocytes at diagnosis \>100X109/L

b. In CR2 or subsequent CR
3. Non-Hodgkin's lymphoma

1. Follicular NHL: in second or subsequent complete or partial remission
2. Mantle cell NHL: in second or subsequent complete or partial remission
3. High grade NHL: in second complete or very good partial remission
4. Hodgkin's disease

a. in second or subsequent complete or partial remission
5. Chronic lymphocytic leukaemia.

1. in second or subsequent remission
2. with adverse risk prognostic features in first remission
6. Acquired bone marrow failure syndromes
7. Other haematological malignancies for which UD bone marrow transplantation is indicated

PATIENT SELECTION

1. Aged under 35 years and greater than 18 years
2. Absence of HLA compatible related donor.
3. Need for an urgent transplantation or absence of HLA-compatible VUD after searching the international registries.
4. Patients with a HLA-compatible VUD but whose donor is considered by the transplantation centre as unsuitable will also be eligible.
5. Availability of suitable UD-UCB unit/s.
6. Informed consent.

1. Age under 70 years and older than 18 years
2. Absence of HLA compatible related donor.
3. Need for an urgent transplantation or absence of HLA-compatible VUD after searching the international registries.
4. Patients with a HLA-compatible VUD but whose donor is considered by the transplantation centre as unsuitable will also be eligible.
5. Availability of suitable UD-UCB unit/s.
6. Informed consent.

Exclusion Criteria

1. Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
2. ECOG performance status worse than 2
3. Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 40%.
4. Hepatic disease, with total bilirubin above 20umol/l or AST \> 3 times upper limit of normal.
5. Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 70% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 60% of predicted.
6. Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
7. Patients who have received previous treatment with Thymoglobulin®
8. HIV or HTLV positive patients.
9. Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
10. Life expectancy severely limited by diseases other than the disease indication for transplant
11. Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
12. Serious psychiatric/ psychological disorders
13. Absence of /inability to provide informed consent
14. Serious diseases that prevent treatments with chemotherapy
15. Myelofibrosis

1. Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
2. ECOG performance status worse than 2
3. Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 35%.
4. Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or AST \> 5 times upper limit of normal.
5. Severe hypoxaemia, pO2 \< 70 mm Hg, with decreased DLCO \< 50% of predicted; or mild hypoxemia, pO2 \< 80 mm Hg with severely decreased DLCO \< 50% of predicted.
6. Impaired renal function (creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% for age, gender, weight).
7. Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
8. Patients who have received previous treatment with Thymoglobulin®
9. HIV or HTLV positive patients.
10. Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
11. Life expectancy severely limited by diseases other than the disease indication for transplant
12. Serious concurrent uncontrolled infection e.g. active tuberculosis, mycoses or viral infection
13. Serious psychiatric/ psychological disorders
14. Absence of /inability to provide informed consent
15. Within 6 months of prior myeloablative transplant.
16. Patients with acute leukaemia in morphological relapse/ persistent/ progressive disease
17. Intermediate or high grade NHL, mantle cell NHL and Hodgkin's disease that is refractory or progressive on salvage therapy.
18. Myelofibrosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No