TriangleNCT01773395 · OUTCOME
18-Month Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 18 months
What was measured
Progression-Free Survival (PFS) at 18 months after randomization. Progression-free survival is defined as time from randomization to progression of disease or death whichever occurs first. Patients with relapse/progressive disease who re-enter remission after vaccination or upon withdrawal of immune suppression alone will not be considered as having disease progression. The primary analysis will be performed using the modified intention-to-treat (ITT) principle, i.e., all transplanted and eligible patients who receive at least one vaccination will be included in the analysis according to the treatment arm they are randomized to. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. Progression is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features
Groups in this outcome
GVAX
GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
Placebo
Placebo vaccine Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
| Group | Source count |
|---|---|
| GVAX | 30 |
| Placebo | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GVAX | 53 | Not reported | 34 | 69 | Not reported |
| Placebo | 55 | Not reported | 35 | 72 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34
- upper Limit
- 69
- value
- 53
- group Id
- OG001
- lower Limit
- 35
- upper Limit
- 72
- value
- 55
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Progression-Free Survival (PFS) at 18 months after randomization. Progression-free survival is defined as time from randomization to progression of disease or death whichever occurs first. Patients with relapse/progressive disease who re-enter remission after vaccination or upon withdrawal of immune suppression alone will not be considered as having disease progression. The primary analysis will be performed using the modified intention-to-treat (ITT) principle, i.e., all transplanted and eligible patients who receive at least one vaccination will be included in the analysis according to the treatment arm they are randomized to. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. Progression is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features is defined by either morphological evidence of acute leukemia or MDS consistent with pre-transplant features
- dispersion Type
- 95% Confidence Interval
- groups
- description
- GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
- id
- OG000
- title
- GVAX
- description
- Placebo vaccine Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 18 months
- title
- 18-Month Progression Free Survival
- type
- PRIMARY
- unit Of Measure
- Percentage
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Preserved source evidence · Not medical advice