UMIN-CTR Clinical Trial

Public title

Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)

Acronym

Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)

Scientific Title

Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)

Scientific Title:Acronym

Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)

Region

Japan

Condition

Acute myeloid leukemia
AML with multilineage dysplasia
Myelodysplastic syndrome
Acute lymphoblastic leukemia
Chronic myeloid leukemia
Adult T cell leukemia/lymphoma
Malignant lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Determine the safety and efficacy of cord blood transplantation after myeloablative or non-myeloablative conditioning regimen in patients with hematological malignancies who have an indication for allogeneic stem cell transplantation but lack a HLA-identical related, a HLA single-antigen mismatched related donor or a HLA identical (by serological typing) unrelated donor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Engraftment rate

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Myeloablative conditioning regimen consists of Ara-C, cyclophosphamide and TBI12Gy.
Nonmyeloablative conditioning regimen consists of fludarabine 180mg/m2, intravenous busulfan 8mg/kg,and TBI 4Gy.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients with hematologic malignancies who have an indication for allogeneic stem cell transplantation
2. Patients lacking HLA-matched (by serological typing) related, HLA single-antigen mismatched related donor or HLA-identical (by serological typing) unrelated donor
3. ECOG PS 0-1
4. Informed consent

Eligible diseases and status
I. AML: regardless of disease status
II. AML with multilineage dysplasia (regardless of disease status)
III.MDS
i)RAEB1,2
ii)RA with transfusion dependence or RA with poor risk cytogenetics
IV. ALL (including Ph ALL): regardless of disease status
V. CML: Chronic phase resistant to tyrosine kinase inhibitors, Acceleration phase or Blast crisis
VI:ATLL acute type or lymphoma type: regardless of disease status
VII: Malignant lymphoma (regardless of disease status

Eligibility for the myeloablative conditioning regimen (patient must fulfill all the following criteria 1-3)
1. Age: 16=<, =<55 years old at enrollment
2. Normal function of major organ: (must fulfill the following criteria a-d)
a. %VC>40%, FEV1.0%>50% and SaO2>70mmHg (SpO2>94%) on room air
b. EF>50%
c. Serum creatinine level <1.5mg/dl
d. T-Bil<1.5mg/dl and ALT within normal limits
3. No history of high-dose chemotherapy (or radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source

Eligibility for the nonmyeloablative conditioning regimen (patient must fulfill any of the following criteria)
1. Age: =>56 years old at enrollment
2. Major organ dysfunction confirmed within the last 28 days before enrollment
a.30%=<%VC=<40%, 40%=<FEV1.0%=<50%, 50mmHg=<SpO2=<70mmHg (SpO2 90-94%) on room air
b. EF: =>30%, =<50%
c. Serum creatinine level: 1.5-2.0mg/dl
d. T-Bil: 1.5-2.0mg/dl or ALT: more than normal limit and within 3 times of UNL
3. A history of high-dose chemotherapy (radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source

Key exclusion criteria

1. Dysfunction of major organ which meets any of the following criteria.
a. T-Bil > 2.0mg/dl
b. Cre > 2.0mg/dl
c. EF >30%
d. %VC <30%, FEV1.0% <40% or SaO2 < 50mmHg on room air (SpO2 <90%)
e. AST: beyond 3 times of UNL
2. Active infection
3. Poorly controlled diabetes mellitus despite the use of insulin
4. Poorly controlled hypertention
5. Severe complications including heart failure, coronary failure, myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia
6. Pregnant, nursing of possible fertile woman
7. Severe mental disorder who is unlikely to be able to participate in the study
8. A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplantation
9. HIV antibody positivity
10. No indication for this study judged by physician in charge

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Terada

Organization

Osaka City University, Graduate School of Medicine

Division name

Hematology

Zip code

Address

1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585 JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Mika Nakamae

Organization

Osaka City University, Graduate School of Medicine

Division name

Clinical research center for hematological malignancies

Zip code

Address

TEL

Homepage URL

Email

crc-hematology@med.osaka-cu.ac.jp

Institute

Hematology, Osaka City University, Graduate School of Medicine

Institute

Department

Personal name

Organization

Hematology, Osaka City University, Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

07

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2009

Year

05

Month

27

Day

Date of IRB

Anticipated trial start date

2009

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

07

Month

16

Day

Last modified on

2012

Year

07

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002482