Blood CancerNCT00186225

Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

A study testing ablative allogeneic hematopoietic cell transplantation in people with Blood Cancer and Blood and Marrow Transplant (BMT), run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies. Read more about this study

Who is it for?: Ages 4 weeks to 50 years
Conditions the study is for: Blood Cancer, Blood and Marrow Transplant (BMT)
What is being tested?: ablative allogeneic hematopoietic cell transplantation
Type of treatment: Surgery or procedure
How many people: 250 participants
Where: 1 siteUnited States
Study dates: Nov 1989to May 2010
Phase: Interventional
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 4 weeks to 50 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

chronic leukemia
lymphoblastic lymphoma
MDS
MPS Exclusion Criteria:- organ dysfunction
HIV positive

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Read the detailed description

Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

Conditions: Blood Cancer, Blood and Marrow Transplant (BMT)
Being tested: ablative allogeneic hematopoietic cell transplantation
Medical subject headings: Hematologic Neoplasms

What participants receive

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

ablative allogeneic hematopoietic cell transplantationProcedure or surgery

What is being measured

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

oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.

Secondary outcomes (2)

Overall Survival
Event Free Survival

Timeline

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

Nov 1989May 2010

First posted16 Sep 2005 (estimated)
Study startNov 1989
Primary completionJun 2007
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Blood CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 250 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00186225
Sponsor's protocol ID: IRB-13390
Other IDs: 75268, BMT22
Status last verified: Apr 2020
First submitted: 13 Sep 2005
Last updated: 9 Apr 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stem Cell Transplantation From Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY)
ClinicalTrials.gov ID: NCT00186225
Acronym / sponsor ID: IRB-13390
Conditions: Blood Cancer, Blood and Marrow Transplant (BMT)
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (estimated)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Nov 1989
Primary completion: Jun 2007 (actual)
Study completion: May 2010 (actual)
First posted: 16 Sep 2005 (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.

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 4 weeks to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

chronic leukemia
lymphoblastic lymphoma
MDS
MPS Exclusion Criteria:- organ dysfunction
HIV positive

Key exclusion criteria (0 listed)

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
ablative allogeneic hematopoietic cell transplantation	Procedure or surgery	–

Primary outcome

oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.

2 secondary outcomes

Overall Survival
Event Free Survival

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.

Related trials for Blood Cancer

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma

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.

Laura Johnston principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ablative allogeneic hematopoietic cell transplantation in people with Blood Cancer and Blood and Marrow Transplant (BMT), run by Stanford University at 1 site in United States.

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 5 inclusion and 0 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: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

oxicity and efficacy of TBI and cyclophosphamide as preparation for hematopoietic cell transplantation from partially matched and unrelated donors.. 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 NCT00186225.

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 9 Apr 2020.