Hematological DiseasePhase 2NCT01359254
Cord Blood Transplantation for Patients With Cancer
A Phase 2 study testing Melphalan, Fludarabine and Antithymocyte Globulin (ATG) in people with Hematological Disease, run by University of Chicago at 1 site in United States.
Trial summary
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Disease
- What is being tested?
- Melphalan, Fludarabine and Antithymocyte Globulin (ATG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory acute leukemia (myeloid or lymphoid)
- Acute leukemia in first remission at high-risk for recurrence
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
Show all 11Show fewer
- Multiple myeloma
- Myelodysplastic syndrome
- Chronic myeloproliferative disease
- Hemoglobinopathies
- Aplastic anemia
Who cannot join
- Zubrod performance status > 2
- Life expectancy is severely limited by concomitant illness
- Patients with severely decreased LVEF or impaired pulmonary function tests
- Estimated Creatinine Clearance <50 ml/min
- Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
Show all 9Show fewer
- HIV-positive
- Patient is pregnant
- Patient or guardian not able to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Read the detailed description
Primary Objective
- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
- To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
- To describe the incidence and severity of acute and chronic GVHD.
- Conditions
- Hematological Disease
- Being tested
- Melphalan, Fludarabine, Antithymocyte Globulin (ATG), Busulfan, Total Body Irradiation (TBI)
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran, Sarcolysin
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
FludarabineDrug
Also called fludarabine phosphate, Fludara
Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG)Drug
ATG is given every other day for 4 days.
BusulfanDrug
Also called Myleran, Busulfex IV
Busulfan is given daily for 4 days.
Total Body Irradiation (TBI)Drug
TBI is given twice on the last day.
| Study group | Role | What they receive |
|---|---|---|
| Conditioning Regimen I | Experimental | Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Receives: Drug: Melphalan; Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG) |
| Conditioning Regimen II | Experimental | Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Receives: Drug: Fludarabine; Drug: Antithymocyte Globulin (ATG); Drug: Busulfan; Drug: Total Body Irradiation (TBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cord Blood Engraftment by Day 100
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.
As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
Measured: 100 days
Secondary outcomes (1)
Survival at Day 100
Percent of subjects who are alive 100 days after the stem cell infusion
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionJun 2012
Why it stopped: did not accrue enough patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematological DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Artz, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359254
- Sponsor's protocol ID
- 10-020-B
- Status last verified
- Apr 2015
- First submitted
- 20 May 2011
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01359254
- Acronym / sponsor ID
- 10-020-B
- Conditions
- Hematological Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: did not accrue enough patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Detailed description
Primary Objective
- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
- To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
- To describe the incidence and severity of acute and chronic GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditioning Regimen I | Experimental | Drug: Melphalan, Drug: Fludarabine, Drug: Antithymocyte Globulin (ATG)Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) |
| Conditioning Regimen II | Experimental | Drug: Fludarabine, Drug: Antithymocyte Globulin (ATG), Drug: Busulfan, Drug: Total Body Irradiation (TBI)Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Relapsed or refractory acute leukemia (myeloid or lymphoid)
- Acute leukemia in first remission at high-risk for recurrence
- Chronic myelogenous leukemia in accelerated phase or blast-crisis
- Chronic myelogenous leukemia in chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
Key exclusion criteria (9 listed)
- Zubrod performance status > 2
- Life expectancy is severely limited by concomitant illness
- Patients with severely decreased LVEF or impaired pulmonary function tests
- Estimated Creatinine Clearance <50 ml/min
- Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
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 |
|---|---|---|
| MelphalanAlso: Alkeran, SarcolysinMelphalan is given daily for 2 days, overlapping with the completion of fludarabine. | Drug | Conditioning Regimen I |
| FludarabineAlso: fludarabine phosphate, FludaraFludarabine is given through the vein daily for 5 days. | Drug | Conditioning Regimen I, Conditioning Regimen II |
| Antithymocyte Globulin (ATG)ATG is given every other day for 4 days. | Drug | Conditioning Regimen I, Conditioning Regimen II |
| BusulfanAlso: Myleran, Busulfex IVBusulfan is given daily for 4 days. | Drug | Conditioning Regimen II |
| Total Body Irradiation (TBI)TBI is given twice on the last day. | Drug | Conditioning Regimen II |
Primary outcome
Cord Blood Engraftment by Day 100
Time frame: 100 days
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
1 secondary outcome
Survival at Day 100
Time frame: 100 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Artz, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan, Fludarabine and Antithymocyte Globulin (ATG) in people with Hematological Disease, run by University of Chicago 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 11 inclusion and 9 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 30 Apr 2015. 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.
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?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cord Blood Engraftment by Day 100 (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2015.